The VITEK 2 Gram-positive Susceptibility Card is recall
The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine…
Why was The VITEK 2 Gram-positive Susceptibility Card is recalled?
There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403). .
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
VITEK 2AST-P652 Test Kit with Catalog #421857 and Lot# 8021232403 Manufactured 11OCT2019, Expires 11APR2021
- Product
- The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine…
- Recalling firm
- Biomerieux Inc
- Quantity
- 1698 cartons (15,940 cards)
- Distribution
- No distribution within the United States. Foreign distribution locations: Netherlands, Luxembourg, Belgium
- Recall date
- April 29, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)