Vitek 2 AST-YS01 recall
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…
Why was Vitek 2 AST-YS01 recalled?
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
lot 281317710, 26-AUG-15; lot 281347810, 22-JUN-16; and lot 281350120, 15-JUL-16.
- 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…
- Recalling firm
- Biomerieux Inc
- Quantity
- 1604/20-card cartons
- Distribution
- Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
- Recall date
- May 20, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)