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VITEK® MS MOULD KIT

BIOMERIEUX SA · Model VITEK® MS MOULD KIT · UDI-DI 03573026437282

PEX Prescription
1
510(k) clearances
431
Adverse events
3
Recalls
8
Facilities

Description

The VITEK® MS MOULD KIT provides the reagents and consumables needed to process samples by protein extraction and inactivation for mould identification from agar plates by the VITEK® MS System.

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.