FDAClass IIMay 20, 2015

Vitek 2 AST-YS06 recall

Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories…

Why was Vitek 2 AST-YS06 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 286303720, expiration 08-APR-15

Product
Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories…
Recalling firm
Biomerieux Inc
Quantity
1,025/20-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)
Open FDA enforcement record Latest recalls