Recall Z-2715-2026
Biomerieux Inc · initiated June 4, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITEK 2 AST-N447 TEST KIT Product reference 424620
Codes / lots: Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.
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.
FDA-determined cause: Process change control
Action taken
Firm began notifying customers on June 4, 2026. Customers are instructed to dispose of pouches from the affected lot (Ref 424620, Lot 0853293604). Customer may choose to inspect each pouch in their inventory and only dispose of those with "P7" on the label, or they may choose to dispose of all cards from Lot 0853293604 in their inventory. Based on individual customer policy, customers may wish to perform retrospective review of resistant results. Customers should distribute the information to all appropriate personnel in their laboratory. If product was transferred or further distributed, customer should notify downstream users/accounts.
Details
- Recall number
- Z-2715-2026
- Initiated
- June 4, 2026
- Posted by FDA
- July 9, 2026
- Product code
- LON – System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Quantity
- 45,900 cards
- Distribution
- International distribution to the countries of Belgium and the Netherlands.
- Recalling firm
- Biomerieux Inc, Hazelwood, MO