VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.
This recall is currently active, issued March 18, 2021. It was issued by Luminex Corporation.
- Company
- Luminex Corporation
- Recall Initiated
- March 18, 2021
- Recall Number
- Z-1488-2021
- Quantity
- 1210 Units
- Firm Location
- Northbrook, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution - United States (nationwide) and the countries of Austria, France, Greece, Japan, Netherlands, Turkey.
Lot / Code Info
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, 16355087, 16347081, 15131075, 15131073, 14069059, 14069058, 14237219, 14237217, 16077012, 16077011, 20167006, 20167001, 20121009, 19140004, 17234005, 17234004, 14191156, 12305380, 12305379, 12303378, 12303377, 12303376, 12303375, 11213075, 11213073, 11213072, 11213071, 12236271, 12236270, 18128008, 12170169, 12170168, 19057001, 12038011, 15075059, 15075058, 20212006, 18172014, 19260006, 19192007, 20007010, 18318001, 12285355, 12285354, 17278007, 14322268, 20086010, 20086006, 12278340, 17096034, 15040037, 15040036, 17307006, 17307004, 18255007, 18255001, 13238308, 12107091, 20094005, 20036009, 18060001, 13087118, 13087117, 18333002, 18318008, 18226015, 20086009, 20086002, 19095007, 18333012, 17048020, 17048019, 13263328, 13263327, 19095014, 19084008, 17048011, 17017010, 14265244, 14265243, 14265242, 18250001, 18172007, 18172003, 18159002, 20133006, 20133004, 19031006, 19031005, 18344009, 12205218, 12205217, 12205216, 19140010, 19140007, 18214013, 20027004, 20212002, 20212001, 16277051, 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, 18072005, 18060009, 18046010, 18046005, 18046004, 18046003, 18046002, 18046001, 18039004, 18037005, 18037004, 18037003, 18037002, 18026002, 17356002, 17347002, 17340004, 17278001, 17242007, 17215001, 17117044, 17096037, 17096035, 17096033, 17096032, 17062026, 16347083, 16299066, 15327109, 15208088, 15131080, 15131079, 15075056, 15033030, 15033029, 15033026, 15020016, 15020015, 14307259, 14265248, 14265247, 14230210, 14230209, 14230201, 14211173, 14211172, 14142111, 14139104, 14043026, 14006008, 13315360, 13315352, 13301349, 13301348, 13301343, 13301342, 13238309, 13227296, 13224285, 13193257, 13186241, 13170229, 13140195, 13140194, 13133184, 13133181, 13127179, 13066087, 13060074, 13051065, 13051062, 13037048, 13008016, 13008009, 13008008, 13003013, 13003012, 13003011, 13003009, 12324413, 12317405, 12310394, 12310392, 12310391, 12303373, 12303372, 12303371, 12303370, 12285357, 12248292, 12248291, 12233259, 12205214, 12205213, 12205211, 12175193, 12175192, 12156162, 12145150, 12145148, 12145147, 12145146, 12145145, 12142138, 12088816, 12086077, 12069058, 12038815, 12038016, 12038015, 12016002, 11339160, 11339159, 11339158, 11339157, 11306147, 11306146, 11306144, 11306142, 11306141, 11236093, 11236092, 11236091, 11236090, 11236087, 11213085, 11213076, 11213074, 11186066, 11186064, 11152047, 11152046, 11152044, 11101028, 11021003, 10295149, 10295148, 10295147, 10295146, 10295145, 10295144, 10295143, 10295142, 10295141, 10295140, 10295139, 10295136, 10295135, 10278163, 10278133, 10278132, 10278131, 10278128, 10276131, 10250119, 10250118, 10250117, 10210115, 10210111, 10210110, 10210109, 10210108, 10210107, 10210106, 10210105, 10182104, 10182103, 10182102, 10182101, 10162085, 10139084, 10110058, 10099033, 10099032, 10035106, 10035105, 10035017R, 10014012, 10014003, 10014001, 09350165, 09350164, 09350163, 09350161, 09350160, 09350159, 09336158, 09336157, 09336150, 09336149, 09336147, 09336146, 09336145, 09336144, 09325138, 09320127, 09313120, 09313119, 09298118, 09298117, 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, 12310398, 12233260, 11339155, 11276116, 13079110, 10278127, 14139110, 13203264, 12053033, 12053031, 11186065, 14069060, 13301350, 10295153, 17307001, 16242043, 13072091, 13066081, 10035014, 14177137, 12079067, 13161217, 13161215, 13245315, 12240287, 10278126, 10278125, 14244221, 11122036, 14052035, 13079102, 13066084, 10210114, 12198204, 12198203, 10043026, 13245313, 13203263, 12170167, 12128117, 12128116, 15208087, 15020013, 14251238, 14251237, 13274334, 13066090, 13051064, 12317408, 12317407, 12317406, 12248289, 12175187, 12175185, 12136133, 12128120, 12111106, 12111105, 12111104, 12111102, 12069053, 12069051, 12061049, 12038019, 12016010, 12016008, 12016007, 11339150, 11213086, 11213070, 11186059, 11186057, 11122039, 11122037, 11101029, 11068018, 11040015, 11040013, 11021004, 10350169, 10350168, 10350166, 10350165, 10336160, 10336159, 10336158, 10336157, 10336156, 10336155, 10295154, 10295152, 10295151, 10210112, 10182097, 10162086, 10119078, 10102045, 10099044, 10099043, 10099042, 10099041, 10099040, 10099039, 10099038, 10099035, 10043022, 10043021, 10035017, 10014010, 10014009, 10014008, 10014007, 09336154, 09336152, 09325142, 09325141, 09325140, 09325139, 09325137, 09293107, 09293105, 09293104, 09288100, 09255076, 09202049, 09163033, 09100008, 13072092, 11021008, 15020017, 14251233, 14083064, 11306138, 10295150, 10278134, 10162091, 10162090, 13008011, 12310393, 14307258, 10350171, 10350170, 14211180, 09293108, 09277087, 14322261, 14083069, 17296006, 11250093, 11250091, 12248297, 11306134, 10336161, 13087115, 09336143, 10119077, 10035018, 09288098, 12271336, 11021005, 12053032, 12219229, 12198197, 12198196, 12128121, 14191158, 14191157, 12198205, 10014011, 19036001, 09350166, 09270083, 14230204, 14083066, 13224290, 12261315, 12261313, 12136132, 12136131, 13003003, 12303369, 13170224, 12268327, 12229250, 12198201, 12045024, 11306139, 11250092, 15020012, 14251239, 12128114, 12128113, 12038020, 12305381, 12271329, 12292363, 12268326, 10035013, 13186248, 13186247, 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
Root Cause
Process control
Action Taken
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.