CLASS II Device recall · Reported 19 Aug 2020 · FDA Enforcement Report

Verigene Processor SP with assay: Luminex recalled

Luminex is recalling Verigene Processor SP with assay: Luminex, Verigene Gram-Positive Blood Culture Nucleic, distributed nationwide in the US. The recall was initiated on 15 Jun 2020 and the FDA has classified it as Class II.

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Lot, batch or date codesVerigene Processor SP, 10-0000-07, GTIN 00840487101483, Serial Numbers: 902, 907, 908, 909, 911, 912, 9098001, 9098002, 9098003, 9098005, 9098006, 9100009, 9100011, 9100012, 9100014, 9121015, 9121017, 9121018, 9121019, 9121021, 9121022, 9135024, 9135026, 9135027, 9135028, 9135029, 9163034, 9163035, 9163038, 9163039, 9163040, 9163041, 9163042, 9163043, 9163044, 9163045, 9163046, 9202047, 9202050, 9202051, 9202052, 9202053, 9202054, 9210055, 9210056, 9210057, 9210058, 9210059, 9210061, 9210062, 9230063, 9230064, 9230065, 9230066, 9230067, 9230068, 9230069, 9230070, 9230074, 9230075, 9255071, 9255072, 9255077, 9255079, 9255080, 9270080, 9270082, 9270084, 9270085, 9270086, 9270087, 9277088, 9277089, 9277090, 9277091, 9277092, 9277093, 9277094, 9288095, 9288096, 9288097, 9288102, 9293103, 9293106, 9293109, 9293111, 9298112, 9298116, 9298117, 9298118, 9313119, 9313120, 9313121, 9313122, 9313123, 9313124, 9320127, 9325138, 9325151, 9325152, 9336144, 9336145, 9336146, 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19325001, 19325002, 19325003, 19325004, 19325005, 19325006, 19325007, 19325008, 19325009, 19325010, 19343001, 19343002, 20007001, 20007002, 20007003, 20007004, 20007005, 20007006, 20007008, 20036001, 20036002, 20036003, 20036004, 20036005, 20036006, 20036007, 20036008, 20036009, 20036010, 20041001, 20048001, 20048002, 20048003, 20048004, 20048005, 20048006, 20048007, 20048008, 20048009, 20048010, 20058001, 20058002, 20058003, 20058004, 20058005, 20058006, 20058007, 20058008, 20058009, 20058010, 20071001, 20071002, 20071003, 20071004, 20071005, 20071006, 20071007, 20071008, 20071009, 20071010, 20086001, 20086002, 20086003, 20086004, 20086005, 20086006, 20086007, 20086008, 20086009, 20086010, 20094001, 20094003, 20094004, 20094005, 20094006, 20094007, 20094008, 20094009, 20094010, 20111001, 20111002, 20111003, 20111004, 20111005, 20111006, 20111007, 20111008, 20111009, 20111010, 20121002, 20121003, 20121004, 20121006, 20121007, 20121008, 20121010, 20133002, 20133004, 20133006, 20133007, D0903, D0908, D0909, D0912, D09135024, D09255073, D09313126, D09320128, D09320129, D09320130, D09320131, D09320132, D09320133, D09320134, D09320135, D09325135, D09325136, D09336157, D09336158, D908 Verigene Processor SP, Refurbished, 10-0000-07R, GTIN 00840487101490, Serial Numbers: 9100008, 9100013, 9121016, 9135023, 9135030, 9163032, 9163033, 9163036, 9202049, 9255076, 9270079, 9270081, 9270083, 9277087, 9288098, 9288099, 9288100, 9293104, 9293105, 9293107, 9293108, 9293110, 9298111, 9313125, 9325137, 9325139, 9325140, 9325141, 9325142, 9336143, 9336151, 9336152, 9336153, 9336154, 9350166, 10014002, 10014004, 10014005, 10014006, 10014007, 10014008, 10014009, 10014010, 10014011, 10035013, 10035014, 10035015, 10035016, 10035017, 10035018, 10035019, 10035020, 10043021, 10043022, 10043026, 10099030, 10099031, 10099035, 10099036, 10099038, 10099039, 10099040, 10099041, 10099042, 10099043, 10099044, 10102045, 10110059, 10119072, 10119075, 10119077, 10119078, 10139079, 10162086, 10162088, 10162090, 10162091, 10182097, 10182098, 10182099, 10210112, 10210113, 10210114, 10250115, 10250124, 10278125, 10278126, 10278127, 10278129, 10278130, 10278134, 10295150, 10295151, 10295152, 10295153, 10295154, 10336155, 10336156, 10336157, 10336158, 10336159, 10336160, 10336161, 10336162, 10336163, 10336164, 10350165, 10350166, 10350167, 10350168, 10350169, 10350170, 10350171, 10350172, 11021001, 11021002, 11021004, 11021005, 11021006, 11021007, 11021008, 11040009, 11040010, 11040011, 11040012, 11040014, 11040015, 11040016, 11068017, 11068018, 11068019, 11068020, 11068021, 11068022, 11068023, 11068024, 11101025, 11101026, 11101028, 11101029, 11101030, 11101031, 11101032, 11122035, 11122036, 11122037, 11122038, 11122039, 11122040, 11186057, 11186058, 11186059, 11186064, 11186065, 11186066, 11213067, 11213068, 11213069, 11213070, 11213082, 11213083, 11213085, 11213086, 11236087, 11236088, 11250090, 11250091, 11250092, 11250097, 11250104, 11276110, 11276115, 11276116, 11276117, 11276118, 11276119, 11276120, 11276126, 11306134, 11306136, 11306138, 11306139, 11306140, 11306143, 11306146, 11306147, 11339150, 11339155, 12016005, 12016006, 12016007, 12016008, 12016009, 12016010, 12038019, 12038020, 12045024, 12045025, 12053031, 12053032, 12053033, 12053035, 12053040, 12061044, 12061046, 12061047, 12061049, 12069051, 12069053, 12069054, 12069058, 12079067, 12086074, 12086077, 12088090, 12107096, 12107100, 12111101, 12111102, 12111103, 12111104, 12111105, 12111106, 12111107, 12128113, 12128114, 12128115, 12128116, 12128117, 12128120, 12128121, 12136130, 12136131, 12136132, 12136133, 12136135, 12142139, 12142140, 12145145, 12145146, 12145148, 12156161, 12156162, 12170167, 12170178, 12175179, 12175180, 12175185, 12175186, 12175187, 12175188, 12175189, 12175190, 12175192, 12175193, 12198196, 12198197, 12198198, 12198199, 12198200, 12198201, 12198202, 12198203, 12198204, 12198205, 12198206, 12198207, 12198208, 12205209, 12205210, 12205211, 12205212, 12205213, 12205214, 12219229, 12219230, 12223241, 12223244, 12223245, 12223246, 12223247, 12223248, 12229249, 12229250, 12229253, 12229254, 12229255, 12229256, 12229257, 12233260, 12233261, 12233265, 12240287, 12240288, 12248289, 12248293, 12248294, 12248295, 12248297, 12248298, 12254299, 12254300, 12254301, 12254302, 12254303, 12261313, 12261315, 12268323, 12268324, 12268325, 12268326, 12268327, 12268328, 12271329, 12271330, 12271331, 12271332, 12271333, 12271334, 12271335, 12271336, 12271337, 12271338, 12278339, 12278341, 12278342, 12278343, 12278344, 12278345, 12278347, 12278348, 12285356, 12285357, 12285358, 12292359, 12292363, 12292368, 12303369, 12303370, 12303371, 12303372, 12303373, 12303374, 12305381, 12305383, 12305384, 12310389, 12310390, 12310391, 12310392, 12310393, 12310396, 12310398, 12317400, 12317401, 12317402, 12317403, 12317404, 12317406, 12317407, 12317408, 12324411, 12324412, 12333426, 12333427, 12333428, 12340438, 13003003, 13003008, 13008011, 13008013, 13008014, 13008017, 13018024, 13018027, 13018028, 13018029, 13024039, 13024040, 13037041, 13037048, 13042059, 13042060, 13051062, 13051063, 13051064, 13051065, 13051066, 13051067, 13051068, 13060080, 13066081, 13066084, 13066085, 13066088, 13066089, 13072091, 13072092, 13072093, 13079101, 13079102, 13079103, 13079104, 13079110, 13087111, 13087114, 13087115, 13092126, 13092129, 13092130, 13105150, 13112151, 13112152, 13112159, 13112160, 13121161, 13121162, 13121163, 13121164, 13121165, 13121166, 13127171, 13127172, 13127173, 13127174, 13127180, 13133182, 13133184, 13133187, 13133188, 13133189, 13133190, 13140191, 13140192, 13140193, 13140194, 13140195, 13140196, 13154209, 13154210, 13161211, 13161214, 13161215, 13161216, 13161217, 13170224, 13170225, 13170226, 13170227, 13170229, 13178231, 13178232, 13178233, 13178234, 13178240, 13186241, 13186245, 13186246, 13186247, 13186248, 13186249, 13193257, 13193258, 13193259, 13193260, 13203261, 13203262, 13203263, 13203264, 13203265, 13203269, 13203270, 13210274, 13210275, 13210276, 13210277, 13210278, 13224281, 13224282, 13224285, 13224287, 13224288, 13227296, 13238301, 13238304, 13238305, 13238306, 13238307, 13238309, 13238310, 13245311, 13245312, 13245313, 13245314, 13245315, 13245318, 13274332, 13274334, 13274335, 13274336, 13274337, 13274340, 13301341, 13301344, 13301347, 13301350, 13315351, 13315353, 13315354, 13315355, 13315358, 13315359, 14006001, 14006009, 14043022, 14043023, 14043024, 14043026, 14043028, 14043029, 14043030, 14052033, 14052034, 14052036, 14062041, 14062042, 14062047, 14062050, 14069051, 14069052, 14069053, 14069060, 14083063, 14083064, 14083065, 14083066, 14083067, 14083068, 14083069, 14090079, 14111081, 14111084, 14111086, 14111087, 14118092, 14118093, 14139103, 14139104, 14139106, 14139107, 14139108, 14139109, 14139110, 14142111, 14142112, 14142114, 14142115, 14142116, 14155121, 14155122, 14155123, 14155124, 14155128, 14177133, 14177134, 14177137, 14177138, 14182142, 14182143, 14182149, 14182150, 14191153, 14191154, 14191155, 14191157, 14191158, 14211177, 14211180, 14218181, 14218182, 14224199, 14230202, 14230203, 14230204, 14230205, 14237215, 14244221, 14244230, 14251233, 14251234, 14251237, 14251238, 14251239, 14251240, 14265241, 14265245, 14265246, 14307256, 14307257, 14307258, 14307259, 14307260, 14322261, 14322262, 14322267, 14322269, 15015004, 15020012, 15020013, 15020014, 15020015, 15020016, 15020017, 15033021, 15033022, 15033024, 15033025, 15040033, 15055044, 15055046, 15075051, 15075053, 15075056, 15075060, 15131071, 15131072, 15131079, 15208081, 15208087, 15208088, 15208089, 15327109, 16049001, 16049002, 16077013, 16125025, 16242041, 16242043, 16277053, 16299061, 16299062, 16299066, 17062026, 17096031, 17096032, 17096033, 17096035, 17096037, 17117044, 17130059, 17177002, 17215005, 17215008, 17215009, 17262010, 17284001, 17284006, 17284009, 17296005, 17296006, 17296007, 17296008, 17296009, 17296010, 17307001, 17307003, 17333001, 17340004, 17347001, 18022003, 18023007, 18024002, 18026003, 18037001, 18037002, 18037003, 18037004, 18037005, 18039004, 18039005, 18046002, 18046003, 18046004, 18046005, 18046010, 18057009, 18060009, 18060010, 18072004, 18072005, 18072009, 18088003, 18088004, 18088005, 18099006, 18120008, 18128004, 18141007, 18150003, 18150004, 18150006, 18156011, 18159014, 18159015, 18172008, 18177012, 18191012, 18205006, 18214007, 18226001, 18226007, 18226011, 18226012, 18226013, 18235005, 18235007, 18235009, 18250008, 18250013, 18255006, 18255008, 18255010, 18255015, 18264002, 18264006, 18264007, 18264008, 18288008, 18299007, 18299008, 18299012, 18318009, 18318015, 18333001, 18344004, 18344008, 19036002, 19036003, 19072006, 19072009, 19084011, 19084012, 19084013, 19084015, 19095001, 19095013, 19123005, 19295001, D09288101

Quantity recalledTotal = 3,016 systems (2240 Verigene Processor SP and 776 Verigene Processor SP Refurbished)

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-2775-2020
FDA event ID: 85872
Recalling firm: Luminex, Austin, TX
Classification: Class II
Status: Terminated
Recall initiated: 15 Jun 2020
FDA classified: 10 Aug 2020
Reported: 19 Aug 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

15 Jun 2020	Recall initiated by company
10 Aug 2020	Classified by FDA	+56 days
19 Aug 2020	Published in enforcement report	+9 days

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

Reason for recall

An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.

Where it was distributed

Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CN, CT, DE, DC, FL,GA, ID, IN, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NB, NV, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN TX, UT, VT, VA, WA, WV, WY, and WI. The countries of Austria, Belgium, Bulgaria, Canada, Chile, China, France, Germany, Greece, Hong Kong, Italy, Japan, Republic of Korea, Kuwait, Macau, Mexico, Netherlands, New Zealand, Republic of Russia, Saudi Arabia, Singapore, Spain, Thailand, Turkey, United Arab Emirate, and United Kingdom.

Nationwide Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine

Questions about this recall

Why was it recalled?

An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.

Which lots are affected?

Verigene Processor SP, 10-0000-07, GTIN 00840487101483, Serial Numbers: 902, 907, 908, 909, 911, 912, 9098001, 9098002, 9098003, 9098005, 9098006, 9100009, 9100011, 9100012, 9100014, 9121015, 9121017, 9121018, 9121019, 9121021, 9121022, 9135024, 9135026, 9135027, 9135028, 9135029, 9163034, 9163035, 9163038, 9163039, 9163040, 9163041, 9163042, 9163043, 9163044, 9163045, 9163046, 9202047, 9202050, 9202051, 9202052, 9202053, 9202054, 9210055, 9210056, 9210057, 9210058, 9210059, 9210061, 9210062, 9230063, 9230064, 9230065, 9230066, 9230067, 9230068, 9230069, 9230070, 9230074, 9230075, 9255071, 9255072, 9255077, 9255079, 9255080, 9270080, 9270082, 9270084, 9270085, 9270086, 9270087, 9277088, 9277089, 9277090, 9277091, 9277092, 9277093, 9277094, 9288095, 9288096, 9288097, 9288102, 9293103, 9293106, 9293109, 9293111, 9298112, 9298116, 9298117, 9298118, 9313119, 9313120, 9313121, 9313122, 9313123, 9313124, 9320127, 9325138, 9325151, 9325152, 9336144, 9336145, 9336146, 9336147, 9336148, 9336149, 9336150, 9336155, 9336156, 9336157, 9336158, 9350159, 9350160, 9350161, 9350163, 9350164, 9350165, 10014001, 10014003, 10014012, 10035017, 10035105, 10035106, 10043023, 10043024, 10043025, 10043027, 10099029, 10099032, 10099033, 10099037, 10102046, 10110047, 10110048, 10110050, 10110051, 10110052, 10110053, 10110055, 10110056, 10110057, 10110058, 10110060, 10110061, 10110062, 10119063, 10119064, 10119065, 10119066, 10139080, 10139081, 10139082, 10139083, 10139084, 10162085, 10162092, 10162093, 10162094, 10182095, 10182096, 10182100, 10182101, 10182102, 10182103, 10182104, 10210105, 10210106, 10210107, 10210108, 10210109, 10210110, 10210111, 10210115, 10250117, 10250118, 10250119, 10250120, 10250121, 10250122, 10250123, 10276131, 10278128, 10278131, 10278132, 10278133, 10278163, 10295135, 10295136, 10295137, 10295138, 10295139, 10295140, 10295141, 10295142, 10295143, 10295144, 10295145, 10295146, 10295147, 10295149, 11021003, 11021008, 11101027, 11101028, 11122033, 11122034, 11152041, 11152042, 11152043, 11152044, 11152045, 11152046, 11152047, 11152048, 11152049, 11152050, 11152051, 11152052, 11152053, 11186054, 11186055, 11186056, 11186061, 11186062, 11186063, 11186064, 11186066, 11213071, 11213072, 11213073, 11213074, 11213075, 11213076, 11213078, 11213079, 11213080, 11213084, 11213085, 11236087, 11236089, 11236090, 11236091, 11236092, 11236093, 11250094, 11250095, 11250096, 11250098, 11250099, 11250100, 11250101, 11250103, 11250105, 11250106, 11250108, 11250109, 11276111, 11276112, 11276113, 11276114, 11276121, 11276122, 11276123, 11276124, 11276125, 11276127, 11276128, 11276129, 11306130, 11306131, 11306132, 11306133, 11306135, 11306136, 11306137, 11306141, 11306142, 11306144, 11306145, 11306146, 11306147, 11306148, 11306149, 11339151, 11339152, 11339153, 11339156, 11339157, 11339158, 11339159, 11339162, 11339163, 11339164, 12016001, 12016002, 12016003, 12016004, 12038011, 12038013, 12038014, 12038015, 12038016, 12038018, 12045021, 12045022, 12045023, 12045026, 12045027, 12045028, 12045029, 12045030, 12053034, 12053035, 12053036, 12053038, 12053039, 12053040, 12061041, 12061042, 12061043, 12061045, 12061048, 12061050, 12069052, 12069055, 12069056, 12069057, 12069058, 12069059, 12069060, 12079061, 12079062, 12079063, 12079064, 12079065, 12079066, 12079068, 12079069, 12079070, 12086071, 12086072, 12086073, 12086075, 12086076, 12086077, 12086078, 12086079, 12086080, 12088081, 12088082, 12088083, 12088084, 12088085, 12088086, 12088087, 12088088, 12088089, 12107091, 12107092, 12107093, 12107094, 12107095, 12107097, 12107098, 12111108, 12111109, 12111110, 12111111, 12111112, 12122056, 12128118, 12128119, 12128122, 12128123, 12128124, 12136125, 12136126, 12136127, 12136128, 12136134, 12136135, 12136136, 12142137, 12142138, 12142141, 12142142, 12145143, 12145144, 12145145, 12145146, 12145147, 12145148, 12145149, 12145150, 12145151, 12145152, 12145153, 12145154, 12156155, 12156156, 12156158, 12156160, 12156161, 12156162, 12156163, 12156164, 12156165, 12156166, 12170168, 12170169, 12170170, 12170171, 12170172, 12170173, 12170174, 12170175, 12170176, 12170177, 12175181, 12175182, 12175183, 12175184, 12175191, 12175192, 12175193, 12198194, 12198195, 12205211, 12205213, 12205214, 12205215, 12205216, 12205217, 12205218, 12212219, 12212220, 12212221, 12212222, 12212223, 12212224, 12212225, 12212226, 12212227, 12212228, 12219231, 12219232, 12219233, 12219234, 12219235, 12219236, 12219237, 12219238, 12223239, 12223240, 12223242, 12223243, 12229251, 12229252, 12229256, 12229258, 12233259, 12233262, 12233263, 12233264, 12233266, 12233267, 12236269, 12236270, 12236271, 12236272, 12236273, 12236274, 12236275, 12236276, 12236277, 12240280, 12240281, 12240282, 12240283, 12240284, 12240285, 12240286, 12248290, 12248291, 12248292, 12248296, 12254304, 12254305, 12254306, 12254307, 12254308, 12261309, 12261310, 12261311, 12261312, 12261314, 12261316, 12261317, 12261318, 12268319, 12268320, 12268321, 12268322, 12278340, 12278346, 12285349, 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D0912, D09135024, D09255073, D09313126, D09320128, D09320129, D09320130, D09320131, D09320132, D09320133, D09320134, D09320135, D09325135, D09325136, D09336157, D09336158, D908 Verigene Processor SP, Refurbished, 10-0000-07R, GTIN 00840487101490, Serial Numbers: 9100008, 9100013, 9121016, 9135023, 9135030, 9163032, 9163033, 9163036, 9202049, 9255076, 9270079, 9270081, 9270083, 9277087, 9288098, 9288099, 9288100, 9293104, 9293105, 9293107, 9293108, 9293110, 9298111, 9313125, 9325137, 9325139, 9325140, 9325141, 9325142, 9336143, 9336151, 9336152, 9336153, 9336154, 9350166, 10014002, 10014004, 10014005, 10014006, 10014007, 10014008, 10014009, 10014010, 10014011, 10035013, 10035014, 10035015, 10035016, 10035017, 10035018, 10035019, 10035020, 10043021, 10043022, 10043026, 10099030, 10099031, 10099035, 10099036, 10099038, 10099039, 10099040, 10099041, 10099042, 10099043, 10099044, 10102045, 10110059, 10119072, 10119075, 10119077, 10119078, 10139079, 10162086, 10162088, 10162090, 10162091, 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Where was it sold?

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

Other products in this recall event

1 other product · FDA event 85872

This product is part of a recall event; the main page for the event is Verigene Processor SP with assay Luminex recalled.

Reported	Class	Recall	Company	Reason	Where
19 Aug 2020	CLASS II	Verigene Processor SP with assay Luminex recalled	Luminex	Device Malfunction	Nationwide

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	Other Bacterial Contamination	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	Other Bacterial Contamination	Nationwide

Other Test Kits & Diagnostics recalls

All 2,661

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	McKesson Consult hCG Urine Cassette recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
7 Oct 2026Device	CLASS II	Systems/units containing affected recalled	Beckman Coulter Mishima K.K	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
30 Sep 2026Device	CLASS II	Vitek 2 Ast-N461 Test Kit, Gram Negative Susceptibility recalled	Biomerieux	Other	MO
23 Sep 2026Device	CLASS II	DASH Rapid PCR Instrument recalled by Nuclein	Nuclein	Device Malfunction	Nationwide