Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Vitek 2 AST-YS01 REF 22 108 Recalled by Biomerieux Inc Due to The test kits have Out-of-Range-Low (OORL) Flucytosine QC...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biomerieux Inc directly.
Affected Products
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.
Quantity: 1604/20-card cartons
Why Was This Recalled?
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.
Where Was This Sold?
Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
About Biomerieux Inc
Biomerieux Inc has 368 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report