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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86124

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 13, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Luminex Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, 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.

Z-0476-2021
Recall number
Z-0476-2021
Initiated
October 13, 2020
Classification
Class II
Status
Terminated
Recalling firm
Luminex Corporation
Quantity
2838 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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 VERIGENESP devices.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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 VERIGENESP devices.

Code information

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, 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

Distribution pattern

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

device · product 2 of 2

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.

Z-0477-2021
Recall number
Z-0477-2021
Initiated
October 13, 2020
Classification
Class II
Status
Terminated
Recalling firm
Luminex Corporation
Quantity
2838 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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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Distribution pattern

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

Field note

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