Biomerieux Inc

Complete recall history across all FDA and CPSC categories — 368 total recalls

Biomerieux Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (368)

FDA medical device enforcement actions by Biomerieux Inc. Showing most recent 50.

Date Product Reason Class
Jan 5, 2026 VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) ... Potential risk of Quality Control failures and/or false resistant antibiotic ... Class II
Mar 14, 2024 VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial sus... Ceftriaxone (cro02n) concentration errors associated with specific recently m... Class I
Feb 6, 2023 MYLA comprises AST Filters in conjunction with VITEK MS; middleware which con... For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as ... Class II
Nov 9, 2022 API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 API 20 E 25 STRIPS, CATALOG 20100 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 VITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 API JAMES 2AMP, CATALOG 70542 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 API VP1 VP2 REAGENTS, CATALOG 70422 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 PPM INDUSTRY COMBOURG BACARA 20PLATES 90MM, CATALOG AEB520100 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478 As the temperature and time out of range was exceeded, product performances c... Class II
Nov 9, 2022 BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011 As the temperature and time out of range was exceeded, product performances c... Class II

View all 368 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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