Class 2 Device Recall Verigene Processor SP

• Date Initiated by Firm: June 15, 2020
• Create Date: August 10, 2020
• Recall Status: Terminated on June 30, 2023
• Recall Number: Z-2775-2020
• Recall Event ID: 85872
• 510(K)Number: K122514
• Product Classification: Gram-positive bacteria and their resistance markers - Product Code PAM
• Product: Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
• Code Information: Verigene Processor SP, 10-0000-07, GTIN 00840487101483, Serial Numbers: 902, 907, 908, 909, 911, 912, 9098001, 9098002, 9098003, 9098005, 9098006, 9100009, 9100011, 9100012, 9100014, 9121015, 9121017, 9121018, 9121019, 9121021, 9121022, 9135024, 9135026, 9135027, 9135028, 9135029, 9163034, 9163035, 9163038, 9163039, 9163040, 9163041, 9163042, 9163043, 9163044, 9163045, 9163046, 9202047, 9202050, 9202051, 9202052, 9202053, 9202054, 9210055, 9210056, 9210057, 9210058, 9210059, 9210061, 9210062, 9230063, 9230064, 9230065, 9230066, 9230067, 9230068, 9230069, 9230070, 9230074, 9230075, 9255071, 9255072, 9255077, 9255079, 9255080, 9270080, 9270082, 9270084, 9270085, 9270086, 9270087, 9277088, 9277089, 9277090, 9277091, 9277092, 9277093, 9277094, 9288095, 9288096, 9288097, 9288102, 9293103, 9293106, 9293109, 9293111, 9298112, 9298116, 9298117, 9298118, 9313119, 9313120, 9313121, 9313122, 9313123, 9313124, 9320127, 9325138, 9325151, 9325152, 9336144, 9336145, 9336146, 9336147, 9336148, 9336149, 9336150, 9336155, 9336156, 9336157, 9336158, 9350159, 9350160, 9350161, 9350163, 9350164, 9350165, 10014001, 10014003, 10014012, 10035017, 10035105, 10035106, 10043023, 10043024, 10043025, 10043027, 10099029, 10099032, 10099033, 10099037, 10102046, 10110047, 10110048, 10110050, 10110051, 10110052, 10110053, 10110055, 10110056, 10110057, 10110058, 10110060, 10110061, 10110062, 10119063, 10119064, 10119065, 10119066, 10139080, 10139081, 10139082, 10139083, 10139084, 10162085, 10162092, 10162093, 10162094, 10182095, 10182096, 10182100, 10182101, 10182102, 10182103, 10182104, 10210105, 10210106, 10210107, 10210108, 10210109, 10210110, 10210111, 10210115, 10250117, 10250118, 10250119, 10250120, 10250121, 10250122, 10250123, 10276131, 10278128, 10278131, 10278132, 10278133, 10278163, 10295135, 10295136, 10295137, 10295138, 10295139, 10295140, 10295141, 10295142, 10295143, 10295144, 10295145, 10295146, 10295147, 10295149, 11021003, 11021008, 11101027, 11101028, 11122033, 11122034, 11152041, 11152042, 11152043, 11152044, 11152045, 11152046, 11152047, 11152048, 11152049, 11152050, 11152051, 11152052, 11152053, 11186054, 11186055, 11186056, 11186061, 11186062, 11186063, 11186064, 11186066, 11213071, 11213072, 11213073, 11213074, 11213075, 11213076, 11213078, 11213079, 11213080, 11213084, 11213085, 11236087, 11236089, 11236090, 11236091, 11236092, 11236093, 11250094, 11250095, 11250096, 11250098, 11250099, 11250100, 11250101, 11250103, 11250105, 11250106, 11250108, 11250109, 11276111, 11276112, 11276113, 11276114, 11276121, 11276122, 11276123, 11276124, 11276125, 11276127, 11276128, 11276129, 11306130, 11306131, 11306132, 11306133, 11306135, 11306136, 11306137, 11306141, 11306142, 11306144, 11306145, 11306146, 11306147, 11306148, 11306149, 11339151, 11339152, 11339153, 11339156, 11339157, 11339158, 11339159, 11339162, 11339163, 11339164, 12016001, 12016002, 12016003, 12016004, 12038011, 12038013, 12038014, 12038015, 12038016, 12038018, 12045021, 12045022, 12045023, 12045026, 12045027, 12045028, 12045029, 12045030, 12053034, 12053035, 12053036, 12053038, 12053039, 12053040, 12061041, 12061042, 12061043, 12061045, 12061048, 12061050, 12069052, 12069055, 12069056, 12069057, 12069058, 12069059, 12069060, 12079061, 12079062, 12079063, 12079064, 12079065, 12079066, 12079068, 12079069, 12079070, 12086071, 12086072, 12086073, 12086075, 12086076, 12086077, 12086078, 12086079, 12086080, 12088081, 12088082, 12088083, 12088084, 12088085, 12088086, 12088087, 12088088, 12088089, 12107091, 12107092, 12107093, 12107094, 12107095, 12107097, 12107098, 12111108, 12111109, 12111110, 12111111, 12111112, 12122056, 12128118, 12128119, 12128122, 12128123, 12128124, 12136125, 12136126, 12136127, 12136128, 12136134, 12136135, 12136136, 12142137, 12142138, 12142141, 12142142, 12145143, 12145144, 12145145, 12145146, 12145147, 12145148, 12145149, 12145150, 12145151, 12145152, 12145153, 12145154, 12156155, 12156156, 12156158, 12156160, 12156161, 12156162, 12156163, 12156164, 12156165, 12156166, 12170168, 12170169, 12170170, 12170171, 12170172, 12170173, 12170174, 12170175, 12170176, 12170177, 12175181, 12175182, 12175183, 12175184, 12175191, 12175192, 12175193, 12198194, 12198195, 12205211, 12205213, 12205214, 12205215, 12205216, 12205217, 12205218, 12212219, 12212220, 12212221, 12212222, 12212223, 12212224, 12212225, 12212226, 12212227, 12212228, 12219231, 12219232, 12219233, 12219234, 12219235, 12219236, 12219237, 12219238, 12223239, 12223240, 12223242, 12223243, 12229251, 12229252, 12229256, 12229258, 12233259, 12233262, 12233263, 12233264, 12233266, 12233267, 12236269, 12236270, 12236271, 12236272, 12236273, 12236274, 12236275, 12236276, 12236277, 12240280, 12240281, 12240282, 12240283, 12240284, 12240285, 12240286, 12248290, 12248291, 12248292, 12248296, 12254304, 12254305, 12254306, 12254307, 12254308, 12261309, 12261310, 12261311, 12261312, 12261314, 12261316, 12261317, 12261318, 12268319, 12268320, 12268321, 12268322, 12278340, 12278346, 12285349, 12285350, 12285351, 12285352, 12285353, 12285354, 12285355, 12285357, 12292360, 12292361, 12292362, 12292364, 12292365, 12292366, 12303370, 12303371, 12303372, 12303373, 12303375, 12303376, 12303377, 12303378, 12305379, 12305380, 12305382, 12305385, 12305386, 12305387, 12305388, 12310391, 12310392, 12310394, 12310397, 12317399, 12317405, 12324409, 12324410, 12324413, 12324414, 12324415, 12324416, 12324417, 12324418, 12333419, 12333420, 12333422, 12333423, 12333424, 12333425, 12333426, 12340429, 12340430, 12340431, 12340432, 12340433, 12340434, 12340435, 12340436, 12340437, 13003004, 13003005, 13003006, 13003007, 13003010, 13003011, 13003012, 13003013, 13008008, 13008009, 13008014, 13008015, 13008020, 13018025, 13018026, 13018027, 13018028, 13018030, 13024031, 13024032, 13024033, 13024034, 13024035, 13024036, 13024037, 13024038, 13024041, 13037042, 13037043, 13037044, 13037045, 13037046, 13037047, 13037048, 13037049, 13037050, 13042051, 13042052, 13042053, 13042055, 13042056, 13042057, 13042058, 13051061, 13051062, 13051063, 13051065, 13051069, 13051070, 13060071, 13060072, 13060073, 13060074, 13060075, 13060076, 13060077, 13060078, 13060079, 13066082, 13066083, 13066086, 13066089, 13072094, 13072095, 13072096, 13072097, 13072098, 13072099, 13072100, 13079105, 13079106, 13079107, 13079108, 13079109, 13087112, 13087113, 13087117, 13087118, 13087119, 13087120, 13092121, 13092122, 13092123, 13092124, 13092125, 13092127, 13092128, 13099131, 13099132, 13099133, 13099134, 13099135, 13099136, 13105142, 13105143, 13105144, 13105145, 13105146, 13105147, 13105148, 13105149, 13112153, 13112154, 13112155, 13112156, 13112157, 13112158, 13121167, 13121168, 13121169, 13121170, 13127175, 13127176, 13127177, 13127178, 13127179, 13133181, 13133183, 13133184, 13133185, 13133186, 13140194, 13140195, 13140198, 13140199, 13140200, 13154201, 13154202, 13154203, 13154204, 13154205, 13154206, 13154207, 13154208, 13161212, 13161213, 13161218, 13161219, 13161220, 13170221, 13170222, 13170223, 13170228, 13170229, 13178236, 13178237, 13178238, 13178239, 13186241, 13186242, 13186243, 13186244, 13186249, 13186250, 13193251, 13193252, 13193253, 13193254, 13193255, 13193256, 13193257, 13203266, 13203267, 13203268, 13210271, 13210272, 13210273, 13210279, 13210280, 13224283, 13224284, 13224285, 13224286, 13224289, 13227291, 13227292, 13227293, 13227294, 13227295, 13227296, 13227297, 13227298, 13227299, 13227300, 13238302, 13238303, 13238308, 13238309, 13245316, 13245317, 13245319, 13245320, 13263321, 13263322, 13263323, 13263324, 13263325, 13263326, 13263327, 13263328, 13263329, 13263330, 13274331, 13274333, 13274338, 13274339, 13274340, 13301341, 13301342, 13301343, 13301345, 13301346, 13301348, 13301349, 13315352, 13315354, 13315355, 13315356, 13315357, 13315360, 14006002, 14006003, 14006004, 14006005, 14006006, 14006007, 14006008, 14006010, 14013011, 14013012, 14013013, 14013014, 14013015, 14013016, 14013017, 14013018, 14013019, 14013020, 14043021, 14043022, 14043025, 14043026, 14043027, 14052031, 14052032, 14052035, 14052037, 14052038, 14052039, 14052040, 14062043, 14062044, 14062045, 14062046, 14062048, 14062049, 14069051, 14069053, 14069054, 14069055, 14069056, 14069057, 14069058, 14069059, 14083061, 14083062, 14083070, 14090071, 14090072, 14090073, 14090074, 14090075, 14090076, 14090077, 14090078, 14090080, 14111082, 14111083, 14111085, 14111088, 14111089, 14111090, 14118091, 14118094, 14118095, 14118096, 14118097, 14118098, 14118099, 14118100, 14139101, 14139102, 14139104, 14139105, 14139106, 14139107, 14142111, 14142112, 14142117, 14142118, 14142119, 14142120, 14155125, 14155126, 14155127, 14155129, 14155130, 14177131, 14177132, 14177136, 14177137, 14177138, 14177139, 14177140, 14177141, 14182144, 14182145, 14182146, 14182147, 14182148, 14182149, 14191151, 14191152, 14191156, 14191159, 14191160, 14196161, 14196162, 14196163, 14196164, 14196165, 14196166, 14196167, 14196168, 14196169, 14196170, 14211171, 14211172, 14211173, 14211174, 14211175, 14211176, 14211178, 14211179, 14218183, 14218184, 14218185, 14218186, 14218187, 14218188, 14218189, 14218190, 14224191, 14224192, 14224194, 14224195, 14224196, 14224197, 14224198, 14224200, 14230201, 14230206, 14230207, 14230208, 14230209, 14230210, 14237211, 14237212, 14237213, 14237214, 14237216, 14237217, 14237218, 14237219, 14237220, 14244222, 14244223, 14244224, 14244225, 14244226, 14244227, 14244228, 14244229, 14251231, 14251232, 14251235, 14251236, 14265242, 14265243, 14265244, 14265247, 14265248, 14265249, 14265250, 14307251, 14307252, 14307253, 14307254, 14307255, 14307257, 14307258, 14307259, 14307260, 14322261, 14322263, 14322264, 14322265, 14322266, 14322268, 15015001, 15015004, 15015008, 15015009, 15015010, 15020011, 15020015, 15020016, 15020019, 15020020, 15033023, 15033026, 15033027, 15033028, 15033029, 15033030, 15040031, 15040032, 15040034, 15040035, 15040036, 15040037, 15040038, 15040039, 15040040, 15055041, 15055042, 15055043, 15055045, 15055047, 15055048, 15055049, 15055050, 15075052, 15075054, 15075055, 15075056, 15075057, 15075058, 15075059, 15096061, 15096062, 15096064, 15096065, 15096066, 15096067, 15096068, 15131073, 15131074, 15131075, 15131076, 15131077, 15131078, 15131079, 15131080, 15208082, 15208083, 15208084, 15208085, 15208086, 15208087, 15208088, 15208090, 15320091, 15320092, 15320093, 15320094, 15320095, 15320096, 15320097, 15320098, 15320099, 15320100, 15327101, 15327102, 15327103, 15327104, 15327105, 15327106, 15327107, 15327108, 15327109, 15327110, 16049003, 16049004, 16049005, 16049006, 16049008, 16049009, 16049010, 16077011, 16077012, 16077014, 16077015, 16077016, 16077017, 16077018, 16077019, 16077020, 16125021, 16125022, 16125023, 16125024, 16125026, 16125027, 16125028, 16125029, 16125030, 16214031, 16214032, 16214033, 16214034, 16214035, 16214037, 16214038, 16214039, 16214040, 16242042, 16242044, 16242045, 16242046, 16242047, 16242048, 16242049, 16242050, 16277051, 16277052, 16277054, 16277055, 16277056, 16277057, 16277058, 16277059, 16277060, 16299063, 16299064, 16299065, 16299066, 16299067, 16299068, 16299069, 16299070, 16319071, 16319072, 16319073, 16319074, 16319075, 16334076, 16334077, 16334078, 16334079, 16334080, 16347081, 16347082, 16347083, 16347085, 16355086, 16355087, 16355088, 16355089, 16355090, 17017001, 17017002, 17017003, 17017004, 17017005, 17017006, 17017007, 17017008, 17017009, 17017010, 17048011, 17048012, 17048013, 17048014, 17048015, 17048016, 17048017, 17048018, 17048019, 17048020, 17062021, 17062022, 17062023, 17062024, 17062025, 17062026, 17062027, 17062028, 17062029, 17062030, 17096032, 17096033, 17096034, 17096035, 17096036, 17096037, 17096038, 17096039, 17096040, 17117041, 17117042, 17117043, 17117044, 17117045, 17117046, 17117047, 17117048, 17117049, 17117050, 17130051, 17130052, 17130053, 17130054, 17130055, 17130056, 17130057, 17130058, 17130060, 17157061, 17157062, 17157063, 17157064, 17157065, 17157066, 17157067, 17157068, 17157069, 17157070, 17177003, 17177004, 17177005, 17177006, 17177007, 17177008, 17177009, 17177010, 17188001, 17188002, 17188003, 17188004, 17188005, 17188006, 17188007, 17188008, 17188009, 17188010, 17215002, 17215003, 17215004, 17215005, 17215006, 17215007, 17234001, 17234002, 17234003, 17234004, 17234005, 17234006, 17234007, 17234008, 17234009, 17234010, 17242001, 17242002, 17242003, 17242004, 17242005, 17242007, 17242008, 17242009, 17242010, 17250001, 17250002, 17250003, 17250004, 17250005, 17250006, 17250007, 17250008, 17250009, 17250010, 17262001, 17262002, 17262003, 17262004, 17262005, 17262006, 17262007, 17262008, 17262009, 17278001, 17278002, 17278003, 17278004, 17278005, 17278006, 17278007, 17278008, 17278009, 17278010, 17284001, 17284002, 17284003, 17284004, 17284005, 17284007, 17284008, 17284009, 17284010, 17296001, 17296002, 17296003, 17296004, 17307004, 17307005, 17307006, 17307007, 17307008, 17307009, 17307010, 17333002, 17333003, 17333004, 17333005, 17340001, 17340002, 17340003, 17340004, 17340005, 17340006, 17340007, 17340008, 17347001, 17347002, 17347003, 17347004, 17347005, 17347006, 17347007, 17353001, 17353002, 17353003, 17353004, 17353005, 17353006, 17353007, 17353008, 17353009, 17353010, 17356001, 17356002, 17356003, 17356004, 17356005, 18022001, 18022002, 18022004, 18022005, 18023001, 18023002, 18023003, 18023004, 18023005, 18023006, 18023008, 18023009, 18023010, 18024001, 18024003, 18024004, 18024005, 18024006, 18024007, 18024008, 18024009, 18024010, 18026001, 18026002, 18026004, 18026005, 18026006, 18026007, 18026008, 18026009, 18026010, 18037002, 18037003, 18037004, 18037005, 18037006, 18037007, 18037008, 18037009, 18037010, 18039001, 18039002, 18039003, 18039004, 18039006, 18039008, 18039009, 18039010, 18046001, 18046002, 18046003, 18046004, 18046005, 18046006, 18046007, 18046008, 18046009, 18046010, 18054001, 18054002, 18054003, 18054004, 18054005, 18054006, 18054007, 18054008, 18054009, 18054010, 18057001, 18057002, 18057003, 18057004, 18057005, 18057006, 18057007, 18057008, 18057010, 18060001, 18060002, 18060003, 18060004, 18060005, 18060006, 18060007, 18060008, 18060009, 18072001, 18072002, 18072003, 18072005, 18072006, 18072007, 18072008, 18072010, 18079001, 18079002, 18079003, 18079004, 18079005, 18079006, 18079007, 18079008, 18079009, 18088001, 18088002, 18088003, 18088005, 18088006, 18088007, 18088008, 18088009, 18088010, 18099001, 18099002, 18099003, 18099004, 18099005, 18099007, 18099008, 18099009, 18099010, 18120001, 18120002, 18120003, 18120004, 18120005, 18120006, 18120007, 18120010, 18128001, 18128002, 18128003, 18128004, 18128005, 18128006, 18128007, 18128008, 18128009, 18128010, 18141001, 18141002, 18141003, 18141004, 18141005, 18141006, 18141008, 18141009, 18141010, 18150001, 18150002, 18150005, 18150007, 18150008, 18150009, 18150010, 18156001, 18156002, 18156003, 18156004, 18156005, 18156006, 18156007, 18156008, 18156009, 18156010, 18156012, 18156013, 18156014, 18156015, 18159001, 18159002, 18159003, 18159004, 18159005, 18159006, 18159007, 18159008, 18159009, 18159010, 18159011, 18159012, 18159013, 18172001, 18172002, 18172003, 18172004, 18172005, 18172006, 18172007, 18172008, 18172009, 18172010, 18172011, 18172012, 18172013, 18172014, 18172015, 18177001, 18177002, 18177003, 18177004, 18177005, 18177006, 18177007, 18177008, 18177009, 18177010, 18177011, 18177012, 18177013, 18177014, 18177015, 18191001, 18191002, 18191003, 18191004, 18191005, 18191007, 18191008, 18191009, 18191010, 18191011, 18191013, 18191014, 18191015, 18205001, 18205002, 18205003, 18205004, 18205005, 18205007, 18205008, 18205009, 18205010, 18205011, 18205012, 18205013, 18205014, 18205015, 18214001, 18214002, 18214003, 18214004, 18214005, 18214008, 18214009, 18214010, 18214011, 18214012, 18214013, 18214014, 18214015, 18226002, 18226003, 18226004, 18226005, 18226006, 18226008, 18226009, 18226010, 18226011, 18226013, 18226014, 18226015, 18235001, 18235002, 18235003, 18235004, 18235005, 18235006, 18235007, 18235008, 18235009, 18235010, 18235011, 18235012, 18235013, 18235014, 18235015, 18250001, 18250002, 18250003, 18250004, 18250005, 18250006, 18250007, 18250009, 18250010, 18250011, 18250012, 18250014, 18250015, 18255001, 18255002, 18255003, 18255004, 18255005, 18255007, 18255009, 18255012, 18255013, 18255014, 18264001, 18264003, 18264004, 18264005, 18264006, 18264008, 18264009, 18264010, 18264011, 18264012, 18264013, 18264014, 18264015, 18288001, 18288002, 18288003, 18288004, 18288005, 18288006, 18288007, 18288008, 18288009, 18288010, 18288011, 18288012, 18288013, 18288014, 18299001, 18299002, 18299004, 18299005, 18299006, 18299008, 18299009, 18299010, 18299011, 18299012, 18299013, 18299014, 18299015, 18318001, 18318002, 18318003, 18318004, 18318005, 18318006, 18318008, 18318009, 18318010, 18318011, 18318012, 18318013, 18318014, 18333001, 18333002, 18333003, 18333004, 18333005, 18333006, 18333007, 18333008, 18333010, 18333011, 18333012, 18333013, 18333014, 18344001, 18344002, 18344003, 18344004, 18344005, 18344006, 18344007, 18344009, 18344010, 18344011, 18344012, 18344013, 18344014, 18344015, 19023001, 19023002, 19023003, 19023004, 19023005, 19031001, 19031002, 19031003, 19031004, 19031005, 19031006, 19031007, 19031008, 19031009, 19031010, 19036001, 19036004, 19036005, 19036006, 19036007, 19036008, 19036009, 19036010, 19044001, 19044002, 19044003, 19044004, 19044005, 19044006, 19044007, 19044008, 19044009, 19044010, 19044011, 19044012, 19044013, 19044014, 19044015, 19057001, 19057003, 19057004, 19057005, 19057006, 19057007, 19057008, 19057009, 19057010, 19057011, 19057012, 19057014, 19057015, 19072002, 19072004, 19072005, 19072006, 19072007, 19072008, 19072009, 19072010, 19072011, 19072012, 19072013, 19072014, 19072015, 19084002, 19084003, 19084004, 19084005, 19084006, 19084007, 19084008, 19084009, 19084010, 19084014, 19092008, 19095001, 19095002, 19095003, 19095004, 19095005, 19095006, 19095007, 19095008, 19095009, 19095010, 19095011, 19095012, 19095013, 19095014, 19095015, 19123001, 19123003, 19123004, 19123006, 19123007, 19123008, 19123009, 19123010, 19140001, 19140002, 19140003, 19140004, 19140005, 19140006, 19140007, 19140008, 19140009, 19140010, 19155001, 19155002, 19155003, 19155004, 19155005, 19155006, 19155007, 19155008, 19155009, 19155010, 19192001, 19192002, 19192003, 19192004, 19192005, 19192006, 19192007, 19192008, 19192009, 19192010, 19206001, 19206002, 19206003, 19206004, 19206006, 19206007, 19206008, 19206009, 19206010, 19233001, 19233002, 19233003, 19233004, 19233005, 19233007, 19233008, 19233009, 19233010, 19260001, 19260002, 19260004, 19260005, 19260006, 19260007, 19260008, 19260009, 19260010, 19281001, 19281002, 19281003, 19281004, 19281005, 19282001, 19282002, 19282003, 19282004, 19282005, 19295001, 19295002, 19295003, 19295004, 19295005, 19295006, 19295007, 19295008, 19295009, 19295010, 19305001, 19305002, 19305003, 19305004, 19305005, 19305006, 19305007, 19305008, 19305009, 19305010, 19317001, 19317002, 19317003, 19317004, 19317005, 19317007, 19317008, 19317009, 19317010, 19325001, 19325002, 19325003, 19325004, 19325005, 19325006, 19325007, 19325008, 19325009, 19325010, 19343001, 19343002, 20007001, 20007002, 20007003, 20007004, 20007005, 20007006, 20007008, 20036001, 20036002, 20036003, 20036004, 20036005, 20036006, 20036007, 20036008, 20036009, 20036010, 20041001, 20048001, 20048002, 20048003, 20048004, 20048005, 20048006, 20048007, 20048008, 20048009, 20048010, 20058001, 20058002, 20058003, 20058004, 20058005, 20058006, 20058007, 20058008, 20058009, 20058010, 20071001, 20071002, 20071003, 20071004, 20071005, 20071006, 20071007, 20071008, 20071009, 20071010, 20086001, 20086002, 20086003, 20086004, 20086005, 20086006, 20086007, 20086008, 20086009, 20086010, 20094001, 20094003, 20094004, 20094005, 20094006, 20094007, 20094008, 20094009, 20094010, 20111001, 20111002, 20111003, 20111004, 20111005, 20111006, 20111007, 20111008, 20111009, 20111010, 20121002, 20121003, 20121004, 20121006, 20121007, 20121008, 20121010, 20133002, 20133004, 20133006, 20133007, D0903, D0908, D0909, D0912, D09135024, D09255073, D09313126, D09320128, D09320129, D09320130, D09320131, D09320132, D09320133, D09320134, D09320135, D09325135, D09325136, D09336157, D09336158, D908 Verigene Processor SP, Refurbished, 10-0000-07R, GTIN 00840487101490, Serial Numbers: 9100008, 9100013, 9121016, 9135023, 9135030, 9163032, 9163033, 9163036, 9202049, 9255076, 9270079, 9270081, 9270083, 9277087, 9288098, 9288099, 9288100, 9293104, 9293105, 9293107, 9293108, 9293110, 9298111, 9313125, 9325137, 9325139, 9325140, 9325141, 9325142, 9336143, 9336151, 9336152, 9336153, 9336154, 9350166, 10014002, 10014004, 10014005, 10014006, 10014007, 10014008, 10014009, 10014010, 10014011, 10035013, 10035014, 10035015, 10035016, 10035017, 10035018, 10035019, 10035020, 10043021, 10043022, 10043026, 10099030, 10099031, 10099035, 10099036, 10099038, 10099039, 10099040, 10099041, 10099042, 10099043, 10099044, 10102045, 10110059, 10119072, 10119075, 10119077, 10119078, 10139079, 10162086, 10162088, 10162090, 10162091, 10182097, 10182098, 10182099, 10210112, 10210113, 10210114, 10250115, 10250124, 10278125, 10278126, 10278127, 10278129, 10278130, 10278134, 10295150, 10295151, 10295152, 10295153, 10295154, 10336155, 10336156, 10336157, 10336158, 10336159, 10336160, 10336161, 10336162, 10336163, 10336164, 10350165, 10350166, 10350167, 10350168, 10350169, 10350170, 10350171, 10350172, 11021001, 11021002, 11021004, 11021005, 11021006, 11021007, 11021008, 11040009, 11040010, 11040011, 11040012, 11040014, 11040015, 11040016, 11068017, 11068018, 11068019, 11068020, 11068021, 11068022, 11068023, 11068024, 11101025, 11101026, 11101028, 11101029, 11101030, 11101031, 11101032, 11122035, 11122036, 11122037, 11122038, 11122039, 11122040, 11186057, 11186058, 11186059, 11186064, 11186065, 11186066, 11213067, 11213068, 11213069, 11213070, 11213082, 11213083, 11213085, 11213086, 11236087, 11236088, 11250090, 11250091, 11250092, 11250097, 11250104, 11276110, 11276115, 11276116, 11276117, 11276118, 11276119, 11276120, 11276126, 11306134, 11306136, 11306138, 11306139, 11306140, 11306143, 11306146, 11306147, 11339150, 11339155, 12016005, 12016006, 12016007, 12016008, 12016009, 12016010, 12038019, 12038020, 12045024, 12045025, 12053031, 12053032, 12053033, 12053035, 12053040, 12061044, 12061046, 12061047, 12061049, 12069051, 12069053, 12069054, 12069058, 12079067, 12086074, 12086077, 12088090, 12107096, 12107100, 12111101, 12111102, 12111103, 12111104, 12111105, 12111106, 12111107, 12128113, 12128114, 12128115, 12128116, 12128117, 12128120, 12128121, 12136130, 12136131, 12136132, 12136133, 12136135, 12142139, 12142140, 12145145, 12145146, 12145148, 12156161, 12156162, 12170167, 12170178, 12175179, 12175180, 12175185, 12175186, 12175187, 12175188, 12175189, 12175190, 12175192, 12175193, 12198196, 12198197, 12198198, 12198199, 12198200, 12198201, 12198202, 12198203, 12198204, 12198205, 12198206, 12198207, 12198208, 12205209, 12205210, 12205211, 12205212, 12205213, 12205214, 12219229, 12219230, 12223241, 12223244, 12223245, 12223246, 12223247, 12223248, 12229249, 12229250, 12229253, 12229254, 12229255, 12229256, 12229257, 12233260, 12233261, 12233265, 12240287, 12240288, 12248289, 12248293, 12248294, 12248295, 12248297, 12248298, 12254299, 12254300, 12254301, 12254302, 12254303, 12261313, 12261315, 12268323, 12268324, 12268325, 12268326, 12268327, 12268328, 12271329, 12271330, 12271331, 12271332, 12271333, 12271334, 12271335, 12271336, 12271337, 12271338, 12278339, 12278341, 12278342, 12278343, 12278344, 12278345, 12278347, 12278348, 12285356, 12285357, 12285358, 12292359, 12292363, 12292368, 12303369, 12303370, 12303371, 12303372, 12303373, 12303374, 12305381, 12305383, 12305384, 12310389, 12310390, 12310391, 12310392, 12310393, 12310396, 12310398, 12317400, 12317401, 12317402, 12317403, 12317404, 12317406, 12317407, 12317408, 12324411, 12324412, 12333426, 12333427, 12333428, 12340438, 13003003, 13003008, 13008011, 13008013, 13008014, 13008017, 13018024, 13018027, 13018028, 13018029, 13024039, 13024040, 13037041, 13037048, 13042059, 13042060, 13051062, 13051063, 13051064, 13051065, 13051066, 13051067, 13051068, 13060080, 13066081, 13066084, 13066085, 13066088, 13066089, 13072091, 13072092, 13072093, 13079101, 13079102, 13079103, 13079104, 13079110, 13087111, 13087114, 13087115, 13092126, 13092129, 13092130, 13105150, 13112151, 13112152, 13112159, 13112160, 13121161, 13121162, 13121163, 13121164, 13121165, 13121166, 13127171, 13127172, 13127173, 13127174, 13127180, 13133182, 13133184, 13133187, 13133188, 13133189, 13133190, 13140191, 13140192, 13140193, 13140194, 13140195, 13140196, 13154209, 13154210, 13161211, 13161214, 13161215, 13161216, 13161217, 13170224, 13170225, 13170226, 13170227, 13170229, 13178231, 13178232, 13178233, 13178234, 13178240, 13186241, 13186245, 13186246, 13186247, 13186248, 13186249, 13193257, 13193258, 13193259, 13193260, 13203261, 13203262, 13203263, 13203264, 13203265, 13203269, 13203270, 13210274, 13210275, 13210276, 13210277, 13210278, 13224281, 13224282, 13224285, 13224287, 13224288, 13227296, 13238301, 13238304, 13238305, 13238306, 13238307, 13238309, 13238310, 13245311, 13245312, 13245313, 13245314, 13245315, 13245318, 13274332, 13274334, 13274335, 13274336, 13274337, 13274340, 13301341, 13301344, 13301347, 13301350, 13315351, 13315353, 13315354, 13315355, 13315358, 13315359, 14006001, 14006009, 14043022, 14043023, 14043024, 14043026, 14043028, 14043029, 14043030, 14052033, 14052034, 14052036, 14062041, 14062042, 14062047, 14062050, 14069051, 14069052, 14069053, 14069060, 14083063, 14083064, 14083065, 14083066, 14083067, 14083068, 14083069, 14090079, 14111081, 14111084, 14111086, 14111087, 14118092, 14118093, 14139103, 14139104, 14139106, 14139107, 14139108, 14139109, 14139110, 14142111, 14142112, 14142114, 14142115, 14142116, 14155121, 14155122, 14155123, 14155124, 14155128, 14177133, 14177134, 14177137, 14177138, 14182142, 14182143, 14182149, 14182150, 14191153, 14191154, 14191155, 14191157, 14191158, 14211177, 14211180, 14218181, 14218182, 14224199, 14230202, 14230203, 14230204, 14230205, 14237215, 14244221, 14244230, 14251233, 14251234, 14251237, 14251238, 14251239, 14251240, 14265241, 14265245, 14265246, 14307256, 14307257, 14307258, 14307259, 14307260, 14322261, 14322262, 14322267, 14322269, 15015004, 15020012, 15020013, 15020014, 15020015, 15020016, 15020017, 15033021, 15033022, 15033024, 15033025, 15040033, 15055044, 15055046, 15075051, 15075053, 15075056, 15075060, 15131071, 15131072, 15131079, 15208081, 15208087, 15208088, 15208089, 15327109, 16049001, 16049002, 16077013, 16125025, 16242041, 16242043, 16277053, 16299061, 16299062, 16299066, 17062026, 17096031, 17096032, 17096033, 17096035, 17096037, 17117044, 17130059, 17177002, 17215005, 17215008, 17215009, 17262010, 17284001, 17284006, 17284009, 17296005, 17296006, 17296007, 17296008, 17296009, 17296010, 17307001, 17307003, 17333001, 17340004, 17347001, 18022003, 18023007, 18024002, 18026003, 18037001, 18037002, 18037003, 18037004, 18037005, 18039004, 18039005, 18046002, 18046003, 18046004, 18046005, 18046010, 18057009, 18060009, 18060010, 18072004, 18072005, 18072009, 18088003, 18088004, 18088005, 18099006, 18120008, 18128004, 18141007, 18150003, 18150004, 18150006, 18156011, 18159014, 18159015, 18172008, 18177012, 18191012, 18205006, 18214007, 18226001, 18226007, 18226011, 18226012, 18226013, 18235005, 18235007, 18235009, 18250008, 18250013, 18255006, 18255008, 18255010, 18255015, 18264002, 18264006, 18264007, 18264008, 18288008, 18299007, 18299008, 18299012, 18318009, 18318015, 18333001, 18344004, 18344008, 19036002, 19036003, 19072006, 19072009, 19084011, 19084012, 19084013, 19084015, 19095001, 19095013, 19123005, 19295001, D09288101
• Recalling Firm/ Manufacturer: Luminex Corporation; 12212 Technology Blvd; Austin TX 78727-6101
• For Additional Information Contact: 512-219-8020
• Manufacturer Reason for Recall: An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
• FDA Determined Cause: Device Design
• Action: On 06/10/2020, the firm sent a letter to customers titled, "MEDICAL DEVICE FIELD ACTION", regarding an instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call. The firm has developed a software solution that identifies and alerts users to the issue. The firm will contact customers to verify their address to ship the software material and provide installation information. Once the update has been completed, customers need to email a screen shot of the updated software, as well as a completed Notice of Destruction to Global Support Services at support@luminexcorp.com to complete the upgrade process. The firm is also stating that until the updated software is installed, it is important, and part of good laboratory practice, that the customer follow the specific guidelines indicated in the current package inserts. Specifically, "Not Detected" test results from a positive blood culture should be evaluated further. The sub-culturing of blood cultures is necessary, per the intended use section within the Package Inserts in the Kits. For any questions contact the firm's Global Support Service at: 1.877.785.2323 (US) 1.512.381.4397 (OUS/CANADA) 512.219.5114 support@luminexcorp.com www.luminexcorp.com
• Quantity in Commerce: Total = 3,016 systems (2240 Verigene Processor SP and 776 Verigene Processor SP Refurbished)
• Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CN, CT, DE, DC, FL,GA, ID, IN, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NB, NV, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN TX, UT, VT, VA, WA, WV, WY, and WI. The countries of Austria, Belgium, Bulgaria, Canada, Chile, China, France, Germany, Greece, Hong Kong, Italy, Japan, Republic of Korea, Kuwait, Macau, Mexico, Netherlands, New Zealand, Republic of Russia, Saudi Arabia, Singapore, Spain, Thailand, Turkey, United Arab Emirate, and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = PAM