CLASS II Device recall · Reported 2 Dec 2020 · FDA Enforcement Report

Verigene Processor SP recalled by Luminex

Luminex is recalling Verigene Processor SP, distributed nationwide in the US. The recall was initiated on 13 Oct 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI 00857573006010 Model Number 10-0000-07, Serial Numbers: 10110051, 10110050, 10110048, 10110047, 10099033, 10099032, 10099029, 10043027, 10043025, 10043024, 10043023, 10035106, 10035105, 10014003, 10014001, 9350165, 9350164, 9350163, 9350161, 9350160, 9350159, 9336156, 9336150, 9336149, 9336148, 9336147, 9336146, 9336145, 9336144, 9325152, 9325151, 9325138, 9320127, 9313124, 9313123, 9313122, 9313121, 9313120, 9313119, 9298118, 9298117, 9298116, 9293111, 9293109, 9293106, 9293103, 9288102, 9288097, 9288096, 9288095, 9277094, 9277093, 9277092, 9277091, 9277090, 9277089, 9277088, 9270087, 9270086, 9270085, 9270084, 9270082, 9270080, 9255080, 9255079, 9255077, 9255072, 9255071, 9230075, 9230074, 9230070, 9230069, 9230068, 9230067, 9230066, 9230065, 9230064, 9230063, 9210062, 9210061, 9210059, 9210058, 9210057, 9210056, 9202052, 9202047, 9163046, 9163045, 9163044, 9163044, 9163043, 9163042, 9163041, 9163040, 9163039, 9163038, 9163035, 9163034, 9135029, 9135028, 9135027, 9135026, 9121022, 9121021, 9121019, 9121018, 9121017, 9121015, 911, 9100014, 9100012, 9100011, 9100009, 9098006, 9098005, 9098003, 9098002, 9098001, 907, 902, 10035017R, 10014012 Correct, 10014012, D09336158, 9336158, D09336157, 9336157, D09135024, 9135024, D0912, 912, D0909, 909, D908, D0908, 908, 18255014, 18150007, 18120010, 18120003, 17333003, 17250008, 17250005, 17250002, 17130060, 17017006, 16334077, 13154206, 13154205, 13154204, 13154203, 13154202, 13008020, 12333423, 12324418, 12324417, 12324416, 12324415, 12324414, 12254308, 12254307, 12254306, 12254305, 12248296, 12333422, 12333420, 12333419, 20212005, 20007006, 20007005, 20007004, 20007002, 20007001, 19317003, 19317002, 19295003, 19095010, 19031003, 18333008, 18318006, 18264010, 18250012, 18250011, 18205003, 18191003, 18060006, 18060006, 17250007, 17234003, 17234002, 17234001, 17017001, 16277051, 15015004, 14211179, 14211178, 14211174, 13178239, 13178238, 13178237, 13178236, 13154201, 13140200, 13140199, 12086072, 12079070, 12079069, 12079065, 9298112, 9210055, 9202054, 12136125, 12128124, 12045028, 12045027, 12045026, 11250109, 11186056, 11186055, 11152050, 11152049, 11152048, 10102046, 18046009, 12061043, 12061042, 18026001, 17250010, 17250009, 19295006, 13105147, 13024036, 13024035, 13024033, 12219234, 12079068, 12079066, 11101027, 11276129, 17242010, 17242009, 17242008, 12107095, 12107094, 12107093, 12107092, 12107091, 18288014, 18288011, 17017003, 14090077, 13105148, 19095002, 13154208, 13154207, 13105146, 12285351, 12285350, 12219238, 12219233, 12053038, 12053036, 11339156, 11213084, 12240286, 12240285, 12240284, 12240283, 12240282, 12240281, 12240280, 12045030, 12045029, 10110062, 10110061, 10110060, 19192009, 19095005, 18054010, 18054009, 18054008, 17117050, 17117049, 17117048, 15327106, 15327105, 15327104, 15327103, 15327102, 15327101, 15320100, 15320099, 15320098, 15320097, 15320096, 15320095, 15320094, 15320093, 14251231, 14244229, 14244228, 13066086, 12205215, 11276128, 11276127, 9202053, 18255004, 18250010, 18172008, 13161218, 13105149, 13105145, 12219236, 12079064, 12079061, 11276121, 11276111, 11152052, 11152051, 10250123, 10250120, 10139083, 10139081, 10139080, 10099037, 14237220, 14237218, 14237216, 15040039, 15040038, 13099133, 13099132, 13099131, 12156156, 12156155, 17234007, 14090075, 14090074, 14090073, 13161219, 11276114, 11276113, 11276112, 10250121, 15327110, 14090076, 13042052, 13024038, 11250095, 11250094, 10182100, 13210280, 13210279, 18288012, 17017002, 13024037, 13024034, 12285353, 12285352, 12285349, 12223239, 12219237, 12219235, 12086071, 11186054, 11152053, 11152045, 10250122, 10139082 Model Number 10-0000-07R, Serial Numbers: 11186058, 9298111, 18255010, 17215009, 17096033, 16277053, 16125025, 15131079, 14191153, 13178234, 20094002, 19295001, 19260003, 19233003, 19206005, 19123005, 19123002, 19095013, 19095001, 19084015, 19084013, 19084012, 19084011, 19084001, 19072009, 19072006, 19057013, 19036003, 19036002, 18344008, 18344004, 18333001, 18318015, 18318009, 18299012, 18299008, 18299007, 18299003, 18288008, 18264008, 18264007, 18264006, 18264002, 18255015, 18255008, 18255006, 18250013, 18250008, 18235009, 18235007, 18235005, 18226013, 18226012, 18226011, 18226007, 18226001, 18214007, 18205006, 18191012, 18177012, 18172008, 18159015, 18159014, 18156011, 18150006, 18150004, 18150003, 18141007, 18128004, 18120008, 18099006, 18088005, 18088004, 18088003, 18072009, 18072005, 18072004, 18060010, 18060009, 18057009, 18046010, 18046005, 18046004, 18046003, 18046002, 18046001, 18039007, 18039005, 18039004, 18037005, 18037004, 18037003, 18037002, 18037001, 18026003, 18024002, 18023007, 18022003, 17347002, 17347001, 17340004, 17333001, 17307003, 17307001, 17296010, 17296009, 17296008, 17296007, 17296006, 17296005, 17284009, 17284006, 17284001, 17278001, 17262010, 17215008, 17215005, 17215001, 17177002, 17177001, 17130059, 17117044, 17096037, 17096035, 17096032, 17096031, 17062026, 16347084, 16299066, 16299062, 16299061, 16242043, 16242041, 16214036, 16077013, 16049002, 16049001, 15327109, 15208089, 15208088, 15208087, 15208081, 15131072, 15131071, 15096063, 15075060, 15075056, 15075053, 15075051, 15055046, 15055044, 15055042, 15040033, 15033025, 15033024, 15033022, 15033021, 15020018, 15020017, 15020016, 15020015, 15020014, 15020013, 15020012, 14322269, 14322267, 14322267, 14322262, 14322261, 14307260, 14307259, 14307258, 14307257, 14307256, 14265246, 14265245, 14265241, 14251240, 14251239, 14251238, 14251237, 14251234, 14251233, 14244230, 14244221, 14237215, 14230205, 14230204, 14230203, 14230202, 14224199, 14218181, 14211180, 14211177, 14211173, 14211172, 14191158, 14191157, 14191155, 14191154, 14182150, 14182149, 14182143, 14182142, 14177138, 14177137, 14177135, 14177134, 14155128, 14155124, 14155123, 14155122, 14155121, 14142116, 14142115, 14142114, 14142112, 14142111, 14139110, 14139109, 14139108, 14139107, 14139106, 14139104, 14139103, 14118093, 14118092, 14111087, 14111086, 14111084, 14111081, 14090079, 14083069, 14083068, 14083067, 14083066, 14083065, 14083064, 14083063, 14069060, 14069053, 14069052, 14069051, 14062050, 14062047, 14062042, 14062041, 14052036, 14052035, 14052034, 14052033, 14043030, 14043029, 14043028, 14043026, 14043024, 14043023, 14043022, 14006009, 14006001, 13315359, 13315358, 13315355, 13315354, 13315353, 13315351, 13301350, 13301347, 13301344, 13301341, 13274340, 13274337, 13274336, 13274335, 13274334, 13274332, 13245318, 13245315, 13245314, 13245313, 13245312, 13245311, 13238310, 13238309, 13238307, 13238306, 13238305, 13238304, 13238301, 13227296, 13224290, 13224288, 13224287, 13224285, 13224282, 13224281, 13210278, 13210277, 13210276, 13210275, 13210274, 13203270, 13203269, 13203265, 13203264, 13203263, 13203262, 13203261, 13193260, 13193258, 13193257, 13186249, 13186248, 13186247, 13186246, 13186245, 13186241, 13178240, 13178233, 13178232, 13178231, 13170229, 13170227, 13170226, 13170225, 13170224, 13161217, 13161216, 13161215, 13161214, 13161211, 13154210, 13154209, 13140197, 13140196, 13140195, 13140194, 13140193, 13140192, 13140191, 13133190, 13133189, 13133188, 13133187, 13133184, 13133182, 13127180, 13127174, 13127173, 13127172, 13127171, 13121166, 13121165, 13121164, 13121163, 13121162, 13121161, 13112160, 13112159, 13112152, 13112151, 13105150, 13099140, 13099139, 13099138, 13099137, 13092130, 13092129, 13092126, 13087116, 13087115, 13087114, 13087111, 13079110, 13079104, 13079103, 13079102, 13079101, 13072093, 13072092, 13072091, 13066089, 13066088, 13066085, 13066084, 13066081, 13060080, 13060074, 13051068, 13051067, 13051066, 13051064, 13051063, 13051062, 13042060, 13042059, 13037048, 13037041, 13024040, 13024039, 13018029, 13018028, 13018027, 13018024, 13008017, 13008014, 13008013, 13008011, 13003008, 13003003, 12340438, 12333428, 12333427, 12333426, 12324412, 12324411, 12317408, 12317407, 12317406, 12317404, 12317403, 12317400, 12310398, 12310396, 12310393, 12310392, 12310391, 12310390, 12310389, 12305384, 12305383, 12305381, 12303374, 12303373, 12303372, 12303371, 12303370, 12303369, 12292368, 12292363, 12292359, 12285358, 12285357, 12285356, 12278348, 12278347, 12278345, 12278344, 12278343, 12278342, 12278341, 12278339, 12271338, 12271337, 12271336, 12271335, 12271334, 12271333, 12271332, 12271331, 12271330, 12271329, 12268328, 12268327, 12268326, 12268323, 12261315, 12261313, 12254303, 12254302, 12254301, 12254300, 12254299, 12248298, 12248297, 12248295, 12248294, 12248293, 12248289, 12240288, 12240287, 12240279, 12236278, 12233265, 12233261, 12233260, 12229257, 12229256, 12229255, 12229254, 12229253, 12229250, 12229249, 12223248, 12223247, 12223246, 12223245, 12223244, 12223241, 12219230, 12219229, 12205214, 12205213, 12205212, 12205211, 12205210, 12205209, 12198208, 12198207, 12198206, 12198205, 12198204, 12198203, 12198202, 12198201, 12198200, 12198199, 12198198, 12198197, 12198196, 12175193, 12175192, 12175188, 12175187, 12175186, 12175185, 12175180, 12170178, 12170174, 12170167, 12156162, 12156161, 12145148, 12145147, 12145146, 12145145, 12142140, 12142139, 12142138, 12136135, 12136133, 12136132, 12136131, 12136129, 12128121, 12128120, 12128117, 12128116, 12128115, 12128114, 12128113, 12111107, 12111106, 12111105, 12111104, 12111103, 12111102, 12111101, 12107100, 12107096, 12088090, 12086077, 12086074, 12069058, 12069051, 12061049, 12061047, 12061044, 12053040, 12053035, 12053033, 12053032, 12053031, 12045025, 12045024, 12038020, 12038019, 12016010, 12016009, 12016008, 12016007, 12016006, 12016005, 11339155, 11339154, 11339150, 11306147, 11306146, 11306143, 11306140, 11306139, 11306138, 11306136, 11306134, 11276120, 11276119, 11276118, 11276117, 11276116, 11276115, 11276110, 11250104, 11250097, 11250092, 11250091, 11236088, 11236087, 11213086, 11213085, 11213083, 11213082, 11213077, 11213070, 11213069, 11213068, 11213067, 11186066, 11186065, 11186064, 11186060, 11186059, 11186057, 11122040, 11122039, 11122038, 11122037, 11122036, 11122035, 11101032, 11101031, 11101030, 11101029, 11101028, 11068022, 11068020, 11068019, 11068018, 11068017, 11040016, 11040015, 11040014, 11040012, 11040011, 11040010, 11040009, 11021008, 11021007, 11021006, 11021005, 11021004, 11021002, 11021001, 10350172, 10350171, 10350170, 10350169, 10350168, 10350167, 10350166, 10350165, 10336164, 10336163, 10336162, 10336161, 10336160, 10336159, 10336158, 10336157, 10336156, 10336155, 10295154, 10295153, 10295152, 10295151, 10295150, 10278134, 10278130, 10278129, 10278127, 10278126, 10278125, 10250124, 10250115, 10210114, 10210113, 10182099, 10182098, 10182097, 10162091, 10162090, 10162088, 10162086, 10139079, 10119077, 10119075, 10119072, 10110059, 10102045, 10099044, 10099043, 10099042, 10099041, 10099040, 10099039, 10099038, 10099036, 10099035, 10099031, 10099030, 10043026, 10043022, 10043021, 10035020, 10035019, 10035018, 10035014, 10035013, 10014011, 10014010, 10014009, 10014008, 10014007, 10014006, 10014005, 10014002, 9350166, 9336154, 9336153, 9336152, 9336151, 9336143, 9325142, 9325141, 9325140, 9325139, 9325137, 9313125, 9293110, 9293108, 9293107, 9293105, 9293104, 9288100, 9288099, 9288098, 9277087, 9270083, 9270081, 9270079, 9255076, 9202049, 9163036, 9163033, 9163032, 9135030, 9135023, 9121016, 9100013, 9100008, 10035017, D09288101, 15015004, 12079067, 11101026, 11101025, 11068024, 11068023, 10035016, 10035015

Quantity recalled2838 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0477-2021
FDA event ID: 86124
Recalling firm: Luminex, Northbrook, IL
Classification: Class II
Status: Terminated
Recall initiated: 13 Oct 2020
FDA classified: 20 Nov 2020
Reported: 2 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

13 Oct 2020	Recall initiated by company
20 Nov 2020	Classified by FDA	+38 days
2 Dec 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENE SP devices.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.

Where it was distributed

Worldwide distribution. US nationwide and Kuwait, Austria, United Kingdom, Spain, France, Chile, Japan, Netherlands, Greece, Italy, Thailand, Germany, Turkey

Nationwide

Questions about this recall

Is Verigene Processor SP recalled?

Yes. Luminex recalled Verigene Processor SP on 13 Oct 2020. The recall is Class II and its status is Terminated. Recall number Z-0477-2021.

Why was it recalled?

Which lots are affected?

UDI 00857573006010 Model Number 10-0000-07, Serial Numbers: 10110051, 10110050, 10110048, 10110047, 10099033, 10099032, 10099029, 10043027, 10043025, 10043024, 10043023, 10035106, 10035105, 10014003, 10014001, 9350165, 9350164, 9350163, 9350161, 9350160, 9350159, 9336156, 9336150, 9336149, 9336148, 9336147, 9336146, 9336145, 9336144, 9325152, 9325151, 9325138, 9320127, 9313124, 9313123, 9313122, 9313121, 9313120, 9313119, 9298118, 9298117, 9298116, 9293111, 9293109, 9293106, 9293103, 9288102, 9288097, 9288096, 9288095, 9277094, 9277093, 9277092, 9277091, 9277090, 9277089, 9277088, 9270087, 9270086, 9270085, 9270084, 9270082, 9270080, 9255080, 9255079, 9255077, 9255072, 9255071, 9230075, 9230074, 9230070, 9230069, 9230068, 9230067, 9230066, 9230065, 9230064, 9230063, 9210062, 9210061, 9210059, 9210058, 9210057, 9210056, 9202052, 9202047, 9163046, 9163045, 9163044, 9163044, 9163043, 9163042, 9163041, 9163040, 9163039, 9163038, 9163035, 9163034, 9135029, 9135028, 9135027, 9135026, 9121022, 9121021, 9121019, 9121018, 9121017, 9121015, 911, 9100014, 9100012, 9100011, 9100009, 9098006, 9098005, 9098003, 9098002, 9098001, 907, 902, 10035017R, 10014012 Correct, 10014012, D09336158, 9336158, D09336157, 9336157, D09135024, 9135024, D0912, 912, D0909, 909, D908, D0908, 908, 18255014, 18150007, 18120010, 18120003, 17333003, 17250008, 17250005, 17250002, 17130060, 17017006, 16334077, 13154206, 13154205, 13154204, 13154203, 13154202, 13008020, 12333423, 12324418, 12324417, 12324416, 12324415, 12324414, 12254308, 12254307, 12254306, 12254305, 12248296, 12333422, 12333420, 12333419, 20212005, 20007006, 20007005, 20007004, 20007002, 20007001, 19317003, 19317002, 19295003, 19095010, 19031003, 18333008, 18318006, 18264010, 18250012, 18250011, 18205003, 18191003, 18060006, 18060006, 17250007, 17234003, 17234002, 17234001, 17017001, 16277051, 15015004, 14211179, 14211178, 14211174, 13178239, 13178238, 13178237, 13178236, 13154201, 13140200, 13140199, 12086072, 12079070, 12079069, 12079065, 9298112, 9210055, 9202054, 12136125, 12128124, 12045028, 12045027, 12045026, 11250109, 11186056, 11186055, 11152050, 11152049, 11152048, 10102046, 18046009, 12061043, 12061042, 18026001, 17250010, 17250009, 19295006, 13105147, 13024036, 13024035, 13024033, 12219234, 12079068, 12079066, 11101027, 11276129, 17242010, 17242009, 17242008, 12107095, 12107094, 12107093, 12107092, 12107091, 18288014, 18288011, 17017003, 14090077, 13105148, 19095002, 13154208, 13154207, 13105146, 12285351, 12285350, 12219238, 12219233, 12053038, 12053036, 11339156, 11213084, 12240286, 12240285, 12240284, 12240283, 12240282, 12240281, 12240280, 12045030, 12045029, 10110062, 10110061, 10110060, 19192009, 19095005, 18054010, 18054009, 18054008, 17117050, 17117049, 17117048, 15327106, 15327105, 15327104, 15327103, 15327102, 15327101, 15320100, 15320099, 15320098, 15320097, 15320096, 15320095, 15320094, 15320093, 14251231, 14244229, 14244228, 13066086, 12205215, 11276128, 11276127, 9202053, 18255004, 18250010, 18172008, 13161218, 13105149, 13105145, 12219236, 12079064, 12079061, 11276121, 11276111, 11152052, 11152051, 10250123, 10250120, 10139083, 10139081, 10139080, 10099037, 14237220, 14237218, 14237216, 15040039, 15040038, 13099133, 13099132, 13099131, 12156156, 12156155, 17234007, 14090075, 14090074, 14090073, 13161219, 11276114, 11276113, 11276112, 10250121, 15327110, 14090076, 13042052, 13024038, 11250095, 11250094, 10182100, 13210280, 13210279, 18288012, 17017002, 13024037, 13024034, 12285353, 12285352, 12285349, 12223239, 12219237, 12219235, 12086071, 11186054, 11152053, 11152045, 10250122, 10139082 Model Number 10-0000-07R, Serial Numbers: 11186058, 9298111, 18255010, 17215009, 17096033, 16277053, 16125025, 15131079, 14191153, 13178234, 20094002, 19295001, 19260003, 19233003, 19206005, 19123005, 19123002, 19095013, 19095001, 19084015, 19084013, 19084012, 19084011, 19084001, 19072009, 19072006, 19057013, 19036003, 19036002, 18344008, 18344004, 18333001, 18318015, 18318009, 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Where was it sold?

Worldwide distribution. US nationwide and Kuwait, Austria, United Kingdom, Spain, France, Chile, Japan, Netherlands, Greece, Italy, Thailand, Germany, Turkey

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Luminex

All 39

Reported	Class	Recall	Company	Reason	Where
11 Jun 2025Device	CLASS II	Verigene Gram Negative Blood Culture (Bc-gn) Nucleic Acid Test recalled	Luminex	Other	Nationwide
14 Aug 2024Device	CLASS II	Verigene Gram Positive Blood Culture (Bc-gp) Nucleic Acid Test recalled	Luminex	Device Malfunction	Nationwide
13 Dec 2023Device	CLASS II	Verigene Bc-gp Utility Tray Carrier) recalled by Luminex	Luminex	Device Malfunction	Nationwide
5 Jul 2023Device	CLASS II	Verigene Enteric Pathogens Nucleic Acid Test (EP) recalled by Luminex	Luminex	Other	Nationwide
5 Jul 2023Device	CLASS II	Verigene Clostridium difficile Nucleic Acid Test recalled by Luminex	Luminex	Botulism	Nationwide

Other Test Kits & Diagnostics recalls

All 2,656

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	STA Staclot Protein S recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	Syva EMIT 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Lead & Heavy Metals	Nationwide
26 Aug 2026Device	CLASS II	Beckman Coulter, Emit 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Lead & Heavy Metals	Nationwide