Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card Recalled by Biomerieux Inc Due to The outer carton label and package insert for...
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
Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
Quantity: 2053 cartons
Why Was This Recalled?
The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
Where Was This Sold?
Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.
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