• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall VERIGENE Processor SP

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall VERIGENE Processor SP see related information
Date Initiated by Firm October 13, 2020
Create Date November 20, 2020
Recall Status1 Open3, Classified
Recall Number Z-0476-2021
Recall Event ID 86124
510(K)Number K143653  
Product Classification Gram-positive bacteria and their resistance markers - Product Code PAM
Product Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.
Code Information UDI 00857573006010 Model Number 10-0000-07, Serial Numbers:  10110051, 10110050, 10110048, 10110047, 10099033, 10099032, 10099029, 10043027, 10043025, 10043024, 10043023, 10035106, 10035105, 10014003, 10014001, 9350165, 9350164, 9350163, 9350161, 9350160, 9350159, 9336156, 9336150, 9336149, 9336148, 9336147, 9336146, 9336145, 9336144, 9325152, 9325151, 9325138, 9320127, 9313124, 9313123, 9313122, 9313121, 9313120, 9313119, 9298118, 9298117, 9298116, 9293111, 9293109, 9293106, 9293103, 9288102, 9288097, 9288096, 9288095, 9277094, 9277093, 9277092, 9277091, 9277090, 9277089, 9277088, 9270087, 9270086, 9270085, 9270084, 9270082, 9270080, 9255080, 9255079, 9255077, 9255072, 9255071, 9230075, 9230074, 9230070, 9230069, 9230068, 9230067, 9230066, 9230065, 9230064, 9230063, 9210062, 9210061, 9210059, 9210058, 9210057, 9210056, 9202052, 9202047, 9163046, 9163045, 9163044, 9163044, 9163043, 9163042, 9163041, 9163040, 9163039, 9163038, 9163035, 9163034, 9135029, 9135028, 9135027, 9135026, 9121022, 9121021, 9121019, 9121018, 9121017, 9121015, 911, 9100014, 9100012, 9100011, 9100009, 9098006, 9098005, 9098003, 9098002, 9098001, 907, 902, 10035017R, 10014012 Correct, 10014012, D09336158, 9336158, D09336157, 9336157, D09135024, 9135024, D0912, 912, D0909, 909, D908, D0908, 908, 18255014, 18150007, 18120010, 18120003, 17333003, 17250008, 17250005, 17250002, 17130060, 17017006, 16334077, 13154206, 13154205, 13154204, 13154203, 13154202, 13008020, 12333423, 12324418, 12324417, 12324416, 12324415, 12324414, 12254308, 12254307, 12254306, 12254305, 12248296, 12333422, 12333420, 12333419, 20212005, 20007006, 20007005, 20007004, 20007002, 20007001, 19317003, 19317002, 19295003, 19095010, 19031003, 18333008, 18318006, 18264010, 18250012, 18250011, 18205003, 18191003, 18060006, 18060006, 17250007, 17234003, 17234002, 17234001, 17017001, 16277051, 15015004, 14211179, 14211178, 14211174, 13178239, 13178238, 13178237, 13178236, 13154201, 13140200, 13140199, 12086072, 12079070, 12079069, 12079065, 9298112, 9210055, 9202054, 12136125, 12128124, 12045028, 12045027, 12045026, 11250109, 11186056, 11186055, 11152050, 11152049, 11152048, 10102046, 18046009, 12061043, 12061042, 18026001, 17250010, 17250009, 19295006, 13105147, 13024036, 13024035, 13024033, 12219234, 12079068, 12079066, 11101027, 11276129, 17242010, 17242009, 17242008, 12107095, 12107094, 12107093, 12107092, 12107091, 18288014, 18288011, 17017003, 14090077, 13105148, 19095002, 13154208, 13154207, 13105146, 12285351, 12285350, 12219238, 12219233, 12053038, 12053036, 11339156, 11213084, 12240286, 12240285, 12240284, 12240283, 12240282, 12240281, 12240280, 12045030, 12045029, 10110062, 10110061, 10110060, 19192009, 19095005, 18054010, 18054009, 18054008, 17117050, 17117049, 17117048, 15327106, 15327105, 15327104, 15327103, 15327102, 15327101, 15320100, 15320099, 15320098, 15320097, 15320096, 15320095, 15320094, 15320093, 14251231, 14244229, 14244228, 13066086, 12205215, 11276128, 11276127, 9202053, 18255004, 18250010, 18172008, 13161218, 13105149, 13105145, 12219236, 12079064, 12079061, 11276121, 11276111, 11152052, 11152051, 10250123, 10250120, 10139083, 10139081, 10139080, 10099037, 14237220, 14237218, 14237216, 15040039, 15040038, 13099133, 13099132, 13099131, 12156156, 12156155, 17234007, 14090075, 14090074, 14090073, 13161219, 11276114, 11276113, 11276112, 10250121, 15327110, 14090076, 13042052, 13024038, 11250095, 11250094, 10182100, 13210280, 13210279, 18288012, 17017002, 13024037, 13024034, 12285353, 12285352, 12285349, 12223239, 12219237, 12219235, 12086071, 11186054, 11152053, 11152045, 10250122, 10139082  Model Number 10-0000-07R, Serial Numbers:  11186058, 9298111, 18255010, 17215009, 17096033, 16277053, 16125025, 15131079, 14191153, 13178234, 20094002, 19295001, 19260003, 19233003, 19206005, 19123005, 19123002, 19095013, 19095001, 19084015, 19084013, 19084012, 19084011, 19084001, 19072009, 19072006, 19057013, 19036003, 19036002, 18344008, 18344004, 18333001, 18318015, 18318009.18299012, 18299008, 18299007, 18299003, 18288008, 18264008, 18264007, 18264006, 18264002, 18255015, 18255008, 18255006, 18250013, 18250008, 18235009, 18235007, 18235005, 18226013, 18226012, 18226011, 18226007, 18226001, 18214007, 18205006, 18191012, 18177012, 18172008, 18159015, 18159014, 18156011, 18150006, 18150004, 18150003, 18141007, 18128004, 18120008, 18099006, 18088005, 18088004, 18088003, 18072009, 18072005, 18072004, 18060010, 18060009, 18057009, 18046010, 18046005, 18046004, 18046003, 18046002, 18046001, 18039007, 18039005, 18039004, 18037005, 18037004, 18037003, 18037002, 18037001, 18026003, 18024002, 18023007, 18022003, 17347002, 17347001, 17340004, 17333001, 17307003, 17307001, 17296010, 17296009, 17296008, 17296007, 17296006, 17296005, 17284009, 17284006, 17284001, 17278001, 17262010, 17215008, 17215005, 17215001, 17177002, 17177001, 17130059, 17117044, 17096037, 17096035, 17096032, 17096031, 17062026, 16347084, 16299066, 16299062, 16299061, 16242043, 16242041, 16214036, 16077013, 16049002, 16049001, 15327109, 15208089, 15208088, 15208087, 15208081, 15131072, 15131071, 15096063, 15075060, 15075056, 15075053, 15075051, 15055046, 15055044, 15055042, 15040033, 15033025, 15033024, 15033022, 15033021, 15020018, 15020017, 15020016, 15020015, 15020014, 15020013, 15020012, 14322269, 14322267, 14322267, 14322262, 14322261, 14307260, 14307259, 14307258, 14307257, 14307256, 14265246, 14265245, 14265241, 14251240, 14251239, 14251238, 14251237, 14251234, 14251233, 14244230, 14244221, 14237215, 14230205, 14230204, 14230203, 14230202, 14224199, 14218181, 14211180, 14211177, 14211173, 14211172, 14191158, 14191157, 14191155, 14191154, 14182150, 14182149, 14182143, 14182142, 14177138, 14177137, 14177135, 14177134, 14155128, 14155124, 14155123, 14155122, 14155121, 14142116, 14142115, 14142114, 14142112, 14142111, 14139110, 14139109, 14139108, 14139107, 14139106, 14139104, 14139103, 14118093, 14118092, 14111087, 14111086, 14111084, 14111081, 14090079, 14083069, 14083068, 14083067, 14083066, 14083065, 14083064, 14083063, 14069060, 14069053, 14069052, 14069051, 14062050, 14062047, 14062042, 14062041, 14052036, 14052035, 14052034, 14052033, 14043030, 14043029, 14043028, 14043026, 14043024, 14043023, 14043022, 14006009, 14006001, 13315359, 13315358, 13315355, 13315354, 13315353, 13315351, 13301350, 13301347, 13301344, 13301341, 13274340, 13274337, 13274336, 13274335, 13274334, 13274332, 13245318, 13245315, 13245314, 13245313, 13245312, 13245311, 13238310, 13238309, 13238307, 13238306, 13238305, 13238304, 13238301, 13227296, 13224290, 13224288, 13224287, 13224285, 13224282, 13224281, 13210278, 13210277, 13210276, 13210275, 13210274, 13203270, 13203269, 13203265, 13203264, 13203263, 13203262, 13203261, 13193260, 13193258, 13193257, 13186249, 13186248, 13186247, 13186246, 13186245, 13186241, 13178240, 13178233, 13178232, 13178231, 13170229, 13170227, 13170226, 13170225, 13170224, 13161217, 13161216, 13161215, 13161214, 13161211, 13154210, 13154209, 13140197, 13140196, 13140195, 13140194, 13140193, 13140192, 13140191, 13133190, 13133189, 13133188, 13133187, 13133184, 13133182, 13127180, 13127174, 13127173, 13127172, 13127171, 13121166, 13121165, 13121164, 13121163, 13121162, 13121161, 13112160, 13112159, 13112152, 13112151, 13105150, 13099140, 13099139, 13099138, 13099137, 13092130, 13092129, 13092126, 13087116, 13087115, 13087114, 13087111, 13079110, 13079104, 13079103, 13079102, 13079101, 13072093, 13072092, 13072091, 13066089, 13066088, 13066085, 13066084, 13066081, 13060080, 13060074, 13051068, 13051067, 13051066, 13051064, 13051063, 13051062, 13042060, 13042059, 13037048, 13037041, 13024040, 13024039, 13018029, 13018028, 13018027, 13018024, 13008017, 13008014, 13008013, 13008011, 13003008, 13003003, 12340438, 12333428, 12333427, 12333426, 12324412, 12324411, 12317408, 12317407, 12317406, 12317404, 12317403, 12317400, 12310398, 12310396, 12310393, 12310392, 12310391, 12310390, 12310389, 12305384, 12305383, 12305381, 12303374, 12303373.12303372, 12303371, 12303370, 12303369, 12292368, 12292363, 12292359, 12285358, 12285357, 12285356, 12278348, 12278347, 12278345, 12278344, 12278343, 12278342, 12278341, 12278339, 12271338, 12271337, 12271336, 12271335, 12271334, 12271333, 12271332, 12271331, 12271330, 12271329, 12268328, 12268327, 12268326, 12268323, 12261315, 12261313, 12254303, 12254302, 12254301, 12254300, 12254299, 12248298, 12248297, 12248295, 12248294, 12248293, 12248289, 12240288, 12240287, 12240279, 12236278, 12233265, 12233261, 12233260, 12229257, 12229256, 12229255, 12229254, 12229253, 12229250, 12229249, 12223248, 12223247, 12223246, 12223245, 12223244, 12223241, 12219230, 12219229, 12205214, 12205213, 12205212, 12205211, 12205210, 12205209, 12198208, 12198207, 12198206, 12198205, 12198204, 12198203, 12198202, 12198201, 12198200, 12198199, 12198198, 12198197, 12198196, 12175193, 12175192, 12175188, 12175187, 12175186, 12175185, 12175180, 12170178, 12170174, 12170167, 12156162, 12156161, 12145148, 12145147, 12145146, 12145145, 12142140, 12142139, 12142138, 12136135, 12136133, 12136132, 12136131, 12136129, 12128121, 12128120, 12128117, 12128116, 12128115, 12128114, 12128113, 12111107, 12111106, 12111105, 12111104, 12111103, 12111102, 12111101, 12107100, 12107096, 12088090, 12086077, 12086074, 12069058, 12069051, 12061049, 12061047, 12061044, 12053040, 12053035, 12053033, 12053032, 12053031, 12045025, 12045024, 12038020, 12038019, 12016010, 12016009, 12016008, 12016007, 12016006, 12016005, 11339155, 11339154, 11339150, 11306147, 11306146, 11306143, 11306140, 11306139, 11306138, 11306136, 11306134, 11276120, 11276119, 11276118, 11276117, 11276116, 11276115, 11276110, 11250104, 11250097, 11250092, 11250091, 11236088, 11236087, 11213086, 11213085, 11213083, 11213082, 11213077, 11213070, 11213069, 11213068, 11213067, 11186066, 11186065, 11186064, 11186060, 11186059, 11186057, 11122040, 11122039, 11122038, 11122037, 11122036, 11122035, 11101032, 11101031, 11101030, 11101029, 11101028, 11068022, 11068020, 11068019, 11068018, 11068017, 11040016, 11040015, 11040014, 11040012, 11040011, 11040010, 11040009, 11021008, 11021007, 11021006, 11021005, 11021004, 11021002, 11021001, 10350172, 10350171, 10350170, 10350169, 10350168, 10350167, 10350166, 10350165, 10336164, 10336163, 10336162, 10336161, 10336160, 10336159, 10336158, 10336157, 10336156, 10336155, 10295154, 10295153, 10295152, 10295151, 10295150, 10278134, 10278130, 10278129, 10278127, 10278126, 10278125, 10250124, 10250115, 10210114, 10210113, 10182099, 10182098, 10182097, 10162091, 10162090, 10162088, 10162086, 10139079, 10119077, 10119075, 10119072, 10110059, 10102045, 10099044, 10099043, 10099042, 10099041, 10099040, 10099039, 10099038, 10099036, 10099035, 10099031, 10099030, 10043026, 10043022, 10043021, 10035020, 10035019, 10035018, 10035014, 10035013, 10014011, 10014010, 10014009, 10014008, 10014007, 10014006, 10014005, 10014002, 9350166, 9336154, 9336153, 9336152, 9336151, 9336143, 9325142, 9325141, 9325140, 9325139, 9325137, 9313125, 9293110, 9293108, 9293107, 9293105, 9293104, 9288100, 9288099, 9288098, 9277087, 9270083, 9270081, 9270079, 9255076, 9202049, 9163036, 9163033, 9163032, 9135030, 9135023, 9121016, 9100013, 9100008, 10035017, D09288101, 15015004, 12079067, 11101026, 11101025, 11068024, 11068023, 10035016, 10035015  
Recalling Firm/
Manufacturer
Luminex Corporation
4088 Commercial Ave
Northbrook IL 60062-1829
Manufacturer Reason
for Recall
Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENESP devices.
FDA Determined
Cause 2
Nonconforming Material/Component
Action On 10/13/2020, the firm sent the following notice: "As part of our corrective action plan, Luminex will be updating software on all VERIGENE SP instruments in the coming weeks, and systematically visiting every VERIGENE customer site to perform a supplemental preventative maintenance on your instruments. We will also likely be sending out a series of Customer Advisory Notifications with additional information on items related to our remediation efforts surrounding the Warning Letter, as well as updates related to other items identified for improved product performance. During this time, you may continue to use your VERIGENE products as directed in the package inserts for each product, or as otherwise directed through further Luminex communications. If you have any question, please do not hesitate to contact Luminex Global Support Services using the contact details below: Luminex Global Support Services 1-877-785-2323 (U.S. and Canada) +1-512-381-4397 (Outside U.S. and Canada) support@luminexcorp.com"
Quantity in Commerce 2838 units
Distribution Worldwide distribution. US nationwide and Kuwait, Austria, United Kingdom, Spain, France, Chile, Japan, Netherlands, Greece, Italy, Thailand, Germany, Turkey
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = PAM and Original Applicant = NANOSPHERE, INC
-
-