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 |
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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