Vitek 2 Gram Positive Susceptibility Test Cards recall
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 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 742343610 exp. 5/11/16, 742347220 exp. 6/16/16, 742350010 exp. 7/14/16, 742352820 exp. 8/11/16, 742355710 exp. 9/9/16, 742362540 exp. 11/16/16, 742364020 exp. 12/1/16, 742368210 exp. 1/12/16, 742376540 exp. 4/5/17, 742383610 exp. 6/15/17, and 742389220 exp. 8/10/17.
- Product
- Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is…
- Recalling firm
- Biomerieux Inc
- Quantity
- 15,006 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)