Vitek 2 AST-YS07 REF 414 967, 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.
Reported: May 20, 2015 Initiated: March 27, 2015 #Z-1602-2015
Product Description
Vitek 2 AST-YS07 REF 414 967, 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
Details
- Recalling Firm
- Biomerieux Inc
- Units Affected
- 43,535/20-card cartons
- Distribution
- Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
- Location
- Hazelwood, MO
Frequently Asked Questions
What product was recalled? ▼
Vitek 2 AST-YS07 REF 414 967, 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.. Recalled by Biomerieux Inc. Units affected: 43,535/20-card cartons.
Why was this product recalled? ▼
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2015. Severity: Moderate. Recall number: Z-1602-2015.
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