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CHROMID® VRE Agar
BIOMERIEUX SA · Model chromID™ VRE Agar · UDI-DI 03573026552138
JSO
Prescription
1
510(k) clearances
764
Adverse events (1 deaths)
56
Recalls
11
Facilities
Description
Chromogenic medium for the qualitative detection of Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE) in stool specimens.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-06 | Hardy Diagnostics | Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae. |
| 2023-05-31 | Remel, Inc | The test medium may not perform as intended. |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.
