Recall Z-2715-2026 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Biomerieux Inc
VITEK 2 AST-N447 TEST KIT Product reference 424620
| Date | Jul 9, 2026 (initiated Jun 4, 2026) |
| Status | Open, Classified |
| Reason | Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures. |
| Root cause | Process change control |
| Action | 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, c |
| Quantity | 45,900 cards |
| Distribution | International distribution to the countries of Belgium and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.