FDAClass IIApril 3, 2013

bioMerieux VITEK 2 AST-ST01 Streptococcus recall

bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of…

Why was bioMerieux VITEK 2 AST-ST01 Streptococcus recalled?

The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.

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 number: 540274420

Product
bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of…
Recalling firm
Biomerieux Inc
Quantity
4/20-card cartons
Distribution
Distributed only in HI.
Recall date
April 3, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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