Recall Z-1603-2015— Biomerieux Inc
Class II · Terminated
Class II FDA medical device recall by Biomerieux Inc, initiated 2015-03-27, terminated 2017-03-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Vitek 2 AST-YS01 REF 22 108, 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.. Reason: The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258..
- Recalling firm
- Biomerieux Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-27
- Terminated
- 2017-03-24
- Firm location
- Hazelwood, MO, United States
Product description
Vitek 2 AST-YS01 REF 22 108, 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.
Reason for recall
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.
Data sourced from openFDA. This site is unofficial and independent of the FDA.