VITEK 2 AST-N447 TEST KIT Product reference 424620

FDA device recall Z-2715-2026 · posted 2026-07-09 · Open, Classified

Recall details

Recalling firm

Biomerieux Inc

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.

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.

Root cause

Process change control

Status

Open, Classified

Product code

LON

Quantity affected

45,900 cards

Distribution

International distribution to the countries of Belgium and the Netherlands.

Date initiated

2026-06-04

Date posted

2026-07-09

Location

Hazelwood, MO