Home › Bruker Daltonik GmbH › MALDI Biotyper sirius one CA System
MALDI Biotyper sirius one CA System
Bruker Daltonik GmbH · Model 1890232 · UDI-DI 04251204326311
PEX
Prescription
1
510(k) clearances
431
Adverse events
3
Recalls
8
Facilities
Description
Biotyper system for clinical use in the USA, with smartbeam 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.