Vitek 2 AST-P641 recall
Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical…
Why was Vitek 2 AST-P641 recalled?
The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
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 741350820, expiration 22JUL16; lot 741340920, expiration 14APR16;
- Product
- Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical…
- Recalling firm
- Biomerieux Inc
- Quantity
- 1505 cartons
- Distribution
- Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.
- Recall date
- April 15, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)