Recall Z-2715-2026— Biomerieux Inc

Name: FDA recall Z-2715-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-04

Class II · Ongoing

Class II FDA medical device recall by Biomerieux Inc, initiated 2026-06-04. Product: VITEK 2 AST-N447 TEST KIT Product reference 424620. Reason: Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures..

Recalling firm: Biomerieux Inc
Classification: Class II
Status: Ongoing
Initiated: 2026-06-04
Firm location: Hazelwood, MO, United States

Product description

VITEK 2 AST-N447 TEST KIT Product reference 424620

Reason for recall

Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.

Data sourced from openFDA. This site is unofficial and independent of the FDA.