Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The VITEK 2 Gram-positive Susceptibility Card is intended for use Recalled by Biomerieux Inc Due to There is a potential for the occurrence of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biomerieux Inc directly.
Affected Products
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 susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.
Quantity: 1698 cartons (15,940 cards)
Why Was This 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). .
Where Was This Sold?
No distribution within the United States. Foreign distribution locations: Netherlands, Luxembourg, Belgium
About Biomerieux Inc
Biomerieux Inc has 368 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report