Vitek 2 Gram Positive Susceptibility Test Cards recall
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is…
Why was Vitek 2 Gram Positive Susceptibility Test Cards recalled?
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
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?
Lots 741340920 exp. 4/14/16, 741350820 exp. 7/22/16, 741356320 exp. 9/15/16, 741357020 exp. 9/22/16, and 741366820 exp. 12/29/16.
- Product
- Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is…
- Recalling firm
- Biomerieux Inc
- Quantity
- 3,594 kits
- Distribution
- Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
- Recall date
- May 18, 2016
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)