Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test,...
FDA Device Recall #Z-2776-2020 — Class II — June 15, 2020
Recall Summary
| Recall Number | Z-2776-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 15, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Luminex Corporation |
| Location | Austin, TX |
| Product Type | Devices |
| Quantity | Total = 3,016 systems (2240 Verigene Processor SP and 776 Verigene Processor SP Refurbished) |
Product Description
Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
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.
Distribution Pattern
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.
Lot / Code Information
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, 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19123009, 19123010, 19140001, 19140002, 19140003, 19140004, 19140005, 19140006, 19140007, 19140008, 19140009, 19140010, 19155001, 19155002, 19155003, 19155004, 19155005, 19155006, 19155007, 19155008, 19155009, 19155010, 19192001, 19192002, 19192003, 19192004, 19192005, 19192006, 19192007, 19192008, 19192009, 19192010, 19206001, 19206002, 19206003, 19206004, 19206006, 19206007, 19206008, 19206009, 19206010, 19233001, 19233002, 19233003, 19233004, 19233005, 19233007, 19233008, 19233009, 19233010, 19260001, 19260002, 19260004, 19260005, 19260006, 19260007, 19260008, 19260009, 19260010, 19281001, 19281002, 19281003, 19281004, 19281005, 19282001, 19282002, 19282003, 19282004, 19282005, 19295001, 19295002, 19295003, 19295004, 19295005, 19295006, 19295007, 19295008, 19295009, 19295010, 19305001, 19305002, 19305003, 19305004, 19305005, 19305006, 19305007, 19305008, 19305009, 19305010, 19317001, 19317002, 19317003, 19317004, 19317005, 19317007, 19317008, 19317009, 19317010, 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
Other Recalls from Luminex Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1903-2025 | Class II | VERIGENE Gram Negative Blood Culture (BC-GN) Nu... | Apr 16, 2025 |
| Z-2533-2024 | Class II | Verigene Gram Positive Blood Culture (BC-GP) Nu... | Jun 20, 2024 |
| Z-0500-2024 | Class II | Luminex VERIGENE BC-GP Utility Tray (5-Pack Car... | Nov 7, 2023 |
| Z-2023-2023 | Class II | Verigene Enteric Pathogens Nucleic Acid Test (E... | Jun 5, 2023 |
| Z-2024-2023 | Class II | VERIGENE Clostridium difficile Nucleic Acid Tes... | Jun 5, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.