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MALDI Biotyper CA System

Bruker Daltonik GmbH · Model 8603464 · UDI-DI 04251204300014

PEX Prescription
5
510(k) clearances
431
Adverse events
3
Recalls
7
Facilities

Description

Biotyper system for clinical use in the USA.

Recalls

DateFirmReason
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed

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Data 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.