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VITEK® 2 GN
BIOMERIEUX , INC. · Model VITEK® 2 GN · UDI-DI 03573026529987
LQM
Prescription
7
510(k) clearances
388
Adverse events (2 deaths)
2
Recalls
11
Facilities
Description
The VITEK® 2 GN Identification Card is intended for use with the VITEK 2 to determine ID of clinically important Gram negative bacteria
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2017-04-20 | Biomerieux Inc | The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). |
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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.