Device product
Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.
Z-1601-2015
Product summary
- Firm
- Biomerieux Inc
- Event
- Event 70868
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,025/20-card cartons
- Official record key
device-enforcement:Z-1601-2015
Official wording
Reason: The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258
Code information: lot 286303720, expiration 08-APR-15
Distribution pattern: Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
Derived failure modes
-
Unknown
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258