Class 2 Device Recall VERIGENE Processor SP

• Date Initiated by Firm: March 18, 2021
• Create Date: April 23, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1488-2021
• Recall Event ID: 87591
• 510(K)Number: K140083
• Product Classification: Gastrointestinal pathogen panel multiplex nucleic acid-based assay system - Product Code PCH
• Product: VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.
• Code Information: VERIGENE Processor SP: Model Number 10-0000-07, UDI 00840487101483; Serial Numbers 19072007, 18255013, 18255002, 18159005, 18159001, 17215007, 21060901, 21055901, 20310901, 18023004, 18023003, 18023002, 18023001, 19072015, 19072014, 18318010, 20261007, 20261004, 20261002, 20167003, 20153009, 20133001, 18344012, 18299005, 18299001, 18250014, 13210273, 13105142, 18235013, 18235010, 18214004, 13186249, 18214011, 17215006, 17188008, 17188007, 17188006, 17188005, 17188004, 17188003, 17188002, 17188001, 17130057, 17130055, 17130054, 17117041, 14196165, 18177009, 18177007, 21039901, 19192005, 14052037, 14142120, 14142119, 19295006, 19044007, 17262004, 14322266, 20094003, 19023004, 19023003, 19023002, 19023001, 16334080, 14218188, 14218187, 20188009, 20188007, 13133183, 19325007, 19325003, 19317010, 19233009, 17096038, 17096036, 18120006, 15208083, 15131078, 15096068, 14062046, 12324410, 12324409, 19260010, 19260005, 13018026, 13018025, 12236277, 18079009, 15096067, 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15015004, 14211179, 14211178, 14211174, 13178239, 13178238, 13178237, 13178236, 13154201, 13140200, 13140199, 18079001, 18022005, 17157061, 18054003, 18054002, 12261312, 12261311, 12261310, 12261309, 12254304, 18128002, 15327108, 15327107, 18128006, 18120004, 18120001, 18099009, 18099007, 11276125, 11276124, 11276123, 11276122, 11186063, 11186062, 11152041, 14251232, 20111002, 20086008, 18177014, 18177006, 9202053, 18288014, 18288011, 18255004, 18250010, 18172008, 17017003, 13161218, 12219236, 12079064, 12079061, 11276121, 11276111, 11152052, 11152051, 10250123, 10250120, 10139083, 10139081, 10139080, 10099037, D908, D09336158, D09336157, D09325136, D09325135, D09320135, D09320134, D09320133, D09320132, D09320131, D09320130, D09320129, D09320128, D09313126, D09255073, D09135024, D0912, D0909, D0908, D0903, 21025901, 20048006, 19233003, 19095013, 19095001, 19072011, 19072009, 19044003, 18344004, 18318009, 18299012, 18299008, 18288008, 18235007, 18235005, 18150009, 18088005, 18088003, 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09298116, 09293111, 09293109, 09293106, 09293103, 09288102, 09288097, 09288096, 09288095, 09270087, 09270086, 09270085, 09270084, 09270082, 09270080, 09255080, 09255079, 09255077, 09255072, 09255071, 09230075, 09230074, 09230070, 09230066, 09230064, 09210062, 09210061, 09210059, 09210058, 09210056, 09202052, 09202047, 09163046, 09163045, 09163044, 09163043, 09163042, 09163040, 09163039, 09163038, 09163035, 09163034, 09135029, 09135028, 09135027, 09135026, 09135024, 09121022, 09121019, 09121018, 09121015, 0912, 0911, 09100014, 09100012, 09100011, 09098006, 09098005, 09098003, 09098002, 09098001, 0909, 0908, 0907, 0902, 20094009, 20094007, 20094006, 20094001, 18226006, 18226005, 13092121, 13087120, 13087119, 17017005, 17017004, 14265250, 14265249, 20058007, 19206006, 13087113, 13087112, 21006901, 21005901, 20353901, 20167009, 20027009, 20027003, 19095002, 13105146, 12285351, 12285350, 12219238, 12219233, 18046008, 18046007, 16049006, 16049005, 18177005, 18177003, 18177001, 18264001, 18172004, 16355090, 15096066, 15096064, 10110052, 10110051, 09230068, 09230067, 18023008, 18022004, 18022002, 18022001, 20133007, 20133002, 20121003, 20111005, 20111003, 19260004, 19233010, 19206007, 19084006, 19072012, 19072005, 19057004, 19057003, 18318011, 18299010, 18250015, 14118091, 14111090, 14224196, 14224195, 18039003, 18039001, 20071003, 20048010, 15040035, 15040034, 15040032, 15040031, 12088089, 12088088, 19343002, 19343001, 16319074, 16319073, 16319072, 16319071, 19282005, 19123006, 20086001, 19155009, 16214040, 16214039, 16214038, 16214037, 12268320, 12268319, 12261318, 12261317, 12261316, 10182096, 10182095, 10162094, 10110057, 19072008, 19057014, 15131077, 15131076, 13121170, 13121169, 14211171, 14196170, 14196169, 21014901, 18141003, 18088010, 18088009, 18088008, 18088007, 18088006, 18159003, 18156010, 15320092, 15320091, 19305001, 15033023, 14251236, 14251235, 19325005, 19317009, 19044008, 18318004, 18299014, 18299013, 19206008, 18079005, 19123008, 19095012, 19123010, 19123001, 10014012 Correct, 20315902, 19095009, 19095004, 19036006, 19036005, 19031002, 18333007, 18318012, 18299006, 18299004, 18264009, 18205007, 19031010, 19031008, 19031007, 14224194, 19317004, 19317001, 19305004, 14052032, 14052031, 12248290, 21062901, 19072013, 16077016, 19072010, 19036008, 17062030, 17062027, 17062024, 14218190, 14218189, 13140198, 18264004, 18264003, 12233264, 16125022, 16125021, 16077020, 15020020, 15020019, 12198195, 12198194, 18344002, 16049010, 16049009, 16049008, 19155010, 19155008, 19155003, 19155002, 19155001, 19123007, 17177009, 17177005, 18172011, 18159011, 19140005, 19123009, 19044013, 19044001, 17157064, 11250098, 11250096, 19095008, 19295008, 19295005, 12128118, 20346901, 21006902, 21021902, 21019901, 21015901, 21005902, 20363901, 20349902, 19295010, 19282004, 19282003, 18250004, 18214015, 18214012, 17296004, 20048007, 20036010, 20036005, 20036001, 19155005, 19044012, 19036004, 18205008, 18156012, 18039009, 18039008, 17117046, 16077018, 12212220, 12212219, 18205014, 18191014, 18191002, 14155125, 18191008, 14230207, 14230206, 14182148, 14182147, 14182146, 14182145, 14182144, 16334076, 15015008, 14322263, 13245317, 13245316, 19057006, 16077019, 14244227, 14244226, 14244225, 14244224, 14142118, 14142117, 13042056, 13042055, 13042053, 18046006, 13186244, 13186243, 13186242, 13003010, 18024010, 18024007, 18024006, 14307252, 14307251, 19044015, 19044014, 18333006, 14196167, 14196166, 19260007, 19260002, 19233007, 14118098, 14118096, 21011901, 13193253, 11339152, 11339151, 18255009, 18255005, 18226009, 18226008, 12061041, 12053039, 11250103, 11250101, 11250100, 11250099, 13060072, 13060071, 13051070, 13051069, 19072004, 18205011, 13224286, 13224284, 13224283, 19057011, 19057009, 19023005, 16299063, 16277060, 17353009, 17353003, 14196161, 14191160, 12069057, 12061048, 19095011, 19095003, 18172006, 18172005, 18172001, 18054005, 17062028, 17048016, 20086007, 13227299, 13227298, 12236276, 14230208, 12088082, 12088081, 12086079, 12086078, 15327110, 14090076, 13042052, 13024038, 11250095, 11250094, 10182100, 21013901, 20153003, 20153002, 18235003, 18214005, 18344015, 18344011, 18214003, 18177015, 17356003, 16355089, 16355088, 17188010, 17188009, 14196164, 14196163, 14196162, 21033901, 19044011, 19044006, 13133186, 13133185 VERIGENE Processor SP, Refurbished: Model Number 10-0000-07R, UDI 00840487101490, Serial Numbers 17307003, 14083065, D09288101, 12170178, 11276119, 11276118, 11276117, 13140192, 13127174, 13112151, 13105150, 13008013, 13238304, 13224288, 12016006, 13238306, 13238305, 13087111, 13210277, 14118093, 11040009, 12198200, 12175186, 12175180, 11101032, 11021001, 10035019, 09336153, 14069051, 13245318, 12254303, 14111087, 14111086, 11236088, 10035020, 09121016, 14251234, 13274336, 13193258, 13133188, 14083063, 13315359, 12142139, 11040012, 13178233, 12271338, 14142115, 14139103, 11213069, 13274340, 12324411, 12248294, 15131071, 15075053, 12340438, 12198198, 12175188, 09163032, 09135030, 13161214, 12317400, 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13178240, 12111101, 10336164, 10336163, 13224287, 13018024, 12278344, 15055044, 15033025, 14083067, 14069053, 13072093, 12278343, 12271337, 14177134, 13301341, 10278129, 13127180, 11101030, 11021006, 10278130, 10099036, 10099030, 13161216, 12142140, 13315358, 12198202, 11101031, 12271330, 12229255
• Recalling Firm/ Manufacturer: Luminex Corporation; 4088 Commercial Ave; Northbrook IL 60062-1829
• For Additional Information Contact: Kate Linak; 847-400-9115
• Manufacturer Reason for Recall: Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.
• FDA Determined Cause: Process control
• Action: A customer advisory notice dated 03/18/2021. The Customer Advisory Notice recommends customers review their QC data to ensure passing results for all VERIGENE EP test targets, and to contact Luminex if any false negatives are observed for any targets within the past twelve months, in order to arrange for a replacement of the Amplification Heater. Additionally, if a Processor SP unit is indicated to have received service 15 on the TSB Log, the Amplification Heater would have already been replaced under routine maintenance with an in specification Amplification Heater and no further action is required for that instrument.
• Quantity in Commerce: 1210 Units
• Distribution: Worldwide distribution - United States (nationwide) and the countries of Austria, France, Greece, Japan, Netherlands, 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 = PCH