VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.
- Company
- Luminex Corporation
- Recall Initiated
- March 18, 2021
- Recall Number
- Z-1488-2021
- Quantity
- 1210 Units
- Firm Location
- Northbrook, IL
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.