Z-1488-2021Class II

VERIGENE Processor SP -

Name: Z-1488-2021 VERIGENE Processor SP -
Creator: Luminex Corporation
Published: 2021-03-18
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2021-03-18 / Open, Classified / root cause: manufacturing process

FDA source

Luminex Corporation began a recall of VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology on 2021-03-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1488-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-03-18
Posted: 2021-04-23
Recalling firm: Luminex Corporation
Product: VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.
Product code: PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 1210 Units
Distribution: Worldwide distribution - United States (nationwide) and the countries of Austria, France, Greece, Japan, Netherlands, Turkey.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1488-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1488-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-05	2021-04-23

Product code PCH

K140083Class IIVerigene Enteric Pathogen Nucleic Acid Test ( Ep)Nanosphere, Inc. / cleared 2014-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)