Biomerieux Inc recalls VITEK 2 AST-N447 TEST KIT Product reference 424620

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-2715-2026
• FDA device classification · LONOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.1645The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Biomerieux IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.