Luminex Corporation: VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.

Recall number

Z-1488-2021

Recalling firm

Luminex Corporation

Product

VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.

Status

Open, Classified

Initiated

2021-03-18

Posted

not on file

Terminated

not on file

Reason

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.

Root 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

1210 Units

Distribution

Worldwide distribution - United States (nationwide) and the countries of Austria, France, Greece, Japan, Netherlands, Turkey.

Lot, serial or model codes

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

510(k) numbers

["K140083"]

PMA numbers

not on file

Product code

PCH

Firm FEI

3006028115

Firm city

Northbrook

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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