--- title: "Biomerieux Inc Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Biomerieux Inc recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/biomerieux-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Biomerieux Inc recall records **102** reported ongoing 105 records in this archive. Latest source date Jun 4, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jun 4, 2026 FDA device enforcement ### [VITEK 2 AST-N447 TEST KIT Product reference 424620](https://isitonrecall.com/recall/fda-device-z-2715-2026-vitek-2-ast-n447-test-kit-product-reference-424620/) Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures. Class II Reported ongoing Distribution: International distribution to the countries of Belgium and the Netherlands. [Official source for VITEK 2 AST-N447 TEST KIT Product reference 424620](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2715-2026%22) Jan 5, 2026 FDA device enforcement ### [VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Rele...](https://isitonrecall.com/recall/fda-device-z-1236-2026-vitek-2-gram-negative-susceptibility-cards-containing-o-polymyxin-b-pb02n-o-ceftazidime-avibactam-cz/) Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibact...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1236-2026%22) Jun 26, 2025 FDA device enforcement ### [VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designe...](https://isitonrecall.com/recall/fda-device-z-2671-2025-vitek-2-gram-negative-ast-test-kits-cards-containing-colistin-formulation-cs02n-vitek-2-is-an-automa/) Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards Class II Reported ongoing Distribution: International distribution in the countries of Albania, Armenia, Australia, Austria, Belgium, Bosnia, Bulgaria, China, Croatia, Cyprus, Czech Republic/Slovakia, France, Germany,... [Official source for VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is a...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2671-2025%22) Mar 14, 2024 FDA device enforcement ### [VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390...](https://isitonrecall.com/recall/fda-device-z-1464-2024-vitek-2-ast-test-kits-in-vitro-diagnostic-test-cards-for-antimicrobial-susceptibility-a-ast-n334-ref/) Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2. Class I Reported ongoing Distribution: Worldwide [Official source for VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1464-2024%22) Feb 6, 2023 FDA device enforcement ### [MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory...](https://isitonrecall.com/recall/fda-device-z-1201-2023-myla-comprises-ast-filters-in-conjunction-with-vitek-ms-middleware-which-connects-microbiology-labor/) For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the clinician. Class II Reported ongoing Distribution: US Nationwide distribution to the states of Alabama, California, North Carolina, and Puerto Rico. [Official source for MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology l...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1201-2023%22) Nov 9, 2022 FDA device enforcement ### [API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300](https://isitonrecall.com/recall/fda-device-z-0783-2023-api-listeria-10-strips-10-media-catalog-10300/) As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0783-2023%22) Nov 9, 2022 FDA device enforcement ### [API 20 E 25 STRIPS, CATALOG 20100](https://isitonrecall.com/recall/fda-device-z-0784-2023-api-20-e-25-strips-catalog-20100/) As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for API 20 E 25 STRIPS, CATALOG 20100](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0784-2023%22) Nov 9, 2022 FDA device enforcement ### [API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210](https://isitonrecall.com/recall/fda-device-z-0785-2023-api-20-c-aux-25-strips-25-media-catalog-20210/) As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0785-2023%22) Nov 9, 2022 FDA device enforcement ### [API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500](https://isitonrecall.com/recall/fda-device-z-0786-2023-api-staph-25-strips-25-media-catalog-20500/) As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0786-2023%22) Nov 9, 2022 FDA device enforcement ### [VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341](https://isitonrecall.com/recall/fda-device-z-0787-2023-vitek-2-reagent-gn-test-kit-vtk2-20-cards-catalog-21341/) As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0787-2023%22) Nov 9, 2022 FDA device enforcement ### [VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342](https://isitonrecall.com/recall/fda-device-z-0788-2023-vitek-2-reagent-gp-test-kit-vtk2-20-cards-catalog-21342/) As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0788-2023%22) Nov 9, 2022 FDA device enforcement ### [VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343](https://isitonrecall.com/recall/fda-device-z-0789-2023-vitek-2-reagent-yst-test-kit-vtk2-20-cards-catalog-21343/) As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0789-2023%22) Nov 9, 2022 FDA device enforcement ### [VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345](https://isitonrecall.com/recall/fda-device-z-0790-2023-vitek-2-reagent-bcl-test-kit-vtk2-20-cards-catalog-21345/) As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0790-2023%22) Nov 9, 2022 FDA device enforcement ### [VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346](https://isitonrecall.com/recall/fda-device-z-0791-2023-vitek-2-reagent-nh-test-kit-vtk2-20-cards-catalog-21346/) As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0791-2023%22) Nov 9, 2022 FDA device enforcement ### [VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226](https://isitonrecall.com/recall/fda-device-z-0792-2023-vitek-2-reagent-ast-gp67-test-kit-20-cards-catalog-22226/) As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0792-2023%22) Nov 9, 2022 FDA device enforcement ### [PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586](https://isitonrecall.com/recall/fda-device-z-0793-2023-previ-color-gram-reagent-iodine-b-na-catalog-29586/) As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0793-2023%22) Nov 9, 2022 FDA device enforcement ### [PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588](https://isitonrecall.com/recall/fda-device-z-0794-2023-previ-color-gram-reagent-nozzle-cleaning-solution-na-catalog-29588/) As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0794-2023%22) Nov 9, 2022 FDA device enforcement ### [VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217](https://isitonrecall.com/recall/fda-device-z-0795-2023-vidas-clinicalvidas-varicel-zoster-igg-60-t-catalog-30217/) As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0795-2023%22) Nov 9, 2022 FDA device enforcement ### [VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219](https://isitonrecall.com/recall/fda-device-z-0796-2023-vidas-clinical-vidas-measles-igg-60tests-catalog-30219/) As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0796-2023%22) Nov 9, 2022 FDA device enforcement ### [VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226](https://isitonrecall.com/recall/fda-device-z-0797-2023-vidas-clinical-vidas-rub-igg-60-tests-catalog-30226/) As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0797-2023%22) ## Reasons in these listed records - Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures. - Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant ... - Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards - Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2. These examples come from this result page and are not a ranking of every recall reason. ## Checking Biomerieux Inc ### Is there a recall on biomerieux inc right now? This archive contains 105 records, including 102 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Biomerieux Inc](https://isitonrecall.com/check/?q=Biomerieux%20Inc) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)