Home › Bruker Scientific LLC › MALDI Biotyper - smart CA
MALDI Biotyper - smart CA
Bruker Scientific LLC · Model 8604784 · UDI-DI 00841594100031
5
510(k) clearances
431
Adverse events
3
Recalls
7
Facilities
Description
Biotyper system for clinical use in the USA, with smart laser.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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.