Is this your brand? Sign in to claim ownership.
Sign in to claim this brandBIOMERIEUX SA
France·FR-MF-000004436
Last updated May 25, 2026
What BIOMERIEUX SA makes
Biomérieux manufactures in vitro diagnostic (IVD) products for bacterial identification and antimicrobial susceptibility testing, including kits for culture isolate identification, lyophilized plasma controls, and antimicrobial resistance testing strips like ETEST®. Their portfolio also includes automated immunoassays for detecting antigens (e.g., dengue NS1) and antibodies (e.g., toxoplasmosis IgM), as well as culture media like SMAC CT Agar and Rappaport broth for bacterial growth.
These devices are classified under EU regulations as Class A, B, C, and II, with corresponding FDA submissions via the 510(k) pathway. The company’s products are registered in the EU’s eudamed database and the FDA’s 510(k) registry. The manufacturer is based in France.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- France
- Address
- 376, Chemin de l'Orme, Marcy-l'Étoile, France
- Website
- biomerieux.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Pierre CHARBONNIER
- EUDAMED SRN
- FR-MF-000004436
- FDA FEI Number
- —
- DUNS Number
- 276816717
Catalogue (140)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Campylosel Agar | 542124 | EUDAMED | Class A | Active |
| ETEST® Amphotericin B (AP) | 543221 | EUDAMED | Class B | Active |
| ETEST® Amoxicillin/Clavulanic Acid (ACC) | 542780 | EUDAMED | Class B | Active |
| ETEST® Erythromycin (EM) | 542889 | EUDAMED | Class B | Active |
| VIDAS® TOXO IgM | 424641 | EUDAMED | Class C | Active |
| Mueller Hinton E Agar | 541962 | EUDAMED | Class B | Active |
| Chocolate agar + PolyViteX™ VCAT3 | 542176 | EUDAMED | Class A | Active |
| VIDAS® High sensitive Troponin I | 415386-30 | EUDAMED | Class C | Active |
| ETEST® Norfloxacin (NX) | 543049 | EUDAMED | Class B | Active |
| ETEST® Streptomycin (SM) | 543041 | EUDAMED | Class B | Active |
| ETEST® Amphotericin-B (AP) | 542785 | EUDAMED | Class B | Active |
| Previ® Color Gram Ra2 Safranin Solution | 29520 | EUDAMED | Class A | Active |
| PORTAGERM™ tubes | 42105 | EUDAMED | Class A | Active |
| VIDAS® Anti-CHIKUNGUNYA IgG | 423230-30 | EUDAMED | Class B | Active |
| Sabouraud Chloramphenicol Actidione Agar | 42094 | EUDAMED | Class A | Active |
| API® Candida | 10500 | EUDAMED | Class B | Active |
| ETEST® Cefpodoxime (PX) | 8308959 | EUDAMED | Class B | Active |
| Schaedler Broth + vit. K3 | 42106 | EUDAMED | Class A | Active |
| VIDAS® 25 OH Vitamin D TOTAL | 30463 | EUDAMED | Class B | Active |
| CHROMID® P. aeruginosa Agar | 542138 | EUDAMED | Class C | Active |
| ETEST® Cefixime (IX) | 8309001 | EUDAMED | Class B | Active |
| ETEST® Spectinomycin (SC) | 8309000 | EUDAMED | Class B | Active |
| ETEST® Amoxicillin (AC) | 8308947 | EUDAMEDFDA UDI | Class B | Active |
| ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | K260447 | EUDAMEDFDA 510(k) | Class II | Active |
| ETEST Plazomicin (PLZ) (0.016-256 µg/mL) | K200512 | FDA 510(k) | Class II | Active |
| Previ® Color Gram Ra3 Acetone Fuchsin Solution | 29521 | EUDAMEDFDA UDI | Class A | Active |
| Ebv R-Gene® | 69-002B | EUDAMED | Class C | Active |
| Vidas® Nephrocheck® | 421172-03 | EUDAMED | Class B | Active |
| Sars-Cov-2/Flua/Flub/Rsv R-Gene® | 424433 | EUDAMED | Class B | Active |
| Emag® Tips 1000µl | 542568 | EUDAMEDFDA UDI | Class A | Active |
| Peptone water | 42085 | EUDAMED | Class A | Active |
| Vidas® B•r•a•h•m•s Pct™ | 30450 | EUDAMED | Class C | Active |
| API® Staph | 20500 | EUDAMEDFDA UDI | Class B | Active |
| Granada™ Agar | 542284 | EUDAMED | Class C | Active |
| Rhino&EV/Cc R-GENE® | 71-042 | EUDAMED | Class B | Active |
| API® NaCl 0.85% Medium | 541047 | EUDAMEDFDA UDI | Class A | Active |
| Covid-19 R-Gene® | 424017 | EUDAMED | Class B | Active |
| VIDAS® IFNg QC PANEL | 424069 | EUDAMED | Class C | Active |
| BK Virus R-GENE® | 69-013B | EUDAMED | Class C | Active |
| Vzv R-Gene® | 71-022 | EUDAMED | Class C | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (100)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Biomérieux SA has 578 FDA recall records initiated between December 23, 2002, and January 5, 2026. The records include recalls with open, classified, and terminated statuses. Reasons cited involve instrument malfunctions—such as electrical short circuits, overheating, or sensor failures—software errors affecting result accuracy or patient data linkage, mislabeled components, and discrepancies in test outcomes, including false positives, prolonged clot times, and incorrect susceptibility results.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 5, 2026 | Z-1236-2026 | — | open, classified | 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 results. |
| Jun 26, 2025 | Z-2671-2025 | — | open, classified | Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards |
| Mar 14, 2024 | Z-1464-2024 | — | open, classified | 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. |
| Feb 6, 2023 | Z-1201-2023 | — | open, classified | 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. |
| Nov 9, 2022 | Z-0787-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0865-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0834-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0796-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0807-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0833-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0803-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0853-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0856-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0875-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0869-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0836-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0872-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0857-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0860-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0814-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0823-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0827-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0847-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0824-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0798-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0870-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0874-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0868-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0837-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0844-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0850-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0813-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0809-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0786-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0826-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0808-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0800-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0785-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0810-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0866-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0867-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0783-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0848-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0830-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0790-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0799-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0832-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0852-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0839-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0812-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0843-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0840-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0792-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0788-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0802-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0791-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0817-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0816-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0806-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0873-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0805-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0825-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0842-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0845-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0829-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0789-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0815-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0797-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0861-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0862-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0854-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0819-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0849-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0846-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0835-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0855-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0858-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0851-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0828-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0801-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0859-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0795-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0876-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0821-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0820-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0863-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0793-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0871-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0818-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0822-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0841-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0794-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0804-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0864-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0831-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0784-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0811-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0838-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Jul 20, 2022 | Z-1564-2022 | — | open, classified | There is a potential of no result leading to possible delayed result due to contamination of extraction reagents. |
| Jul 13, 2022 | Z-1640-2022 | — | open, classified | There are 7 reported software anomalies that may affect use of the device. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Biomérieux US