Z-2715-2026Class II

VITEK 2 AST-N447 TEST KIT Product reference 424620

Name: Z-2715-2026 VITEK 2 AST-N447 TEST KIT Product reference 424620
Creator: Biomerieux Inc
Published: 2026-06-04
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2026-06-04 / Open, Classified / root cause: packaging

FDA source

Biomerieux Inc began a recall of VITEK 2 AST-N447 TEST KIT Product reference 424620 on 2026-06-04. FDA classified it as Class II and gives the reason as "Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2715-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-04
Posted: 2026-07-09
Recalling firm: bioMerieux, Inc.
Product: VITEK 2 AST-N447 TEST KIT Product reference 424620
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
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.
Root cause tag: packaging
FDA 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, customer should notify downstream users/accounts.
Quantity in commerce: 45,900 cards
Distribution: International distribution to the countries of Belgium and the Netherlands.
Product codes and lots: Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2715-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2715-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-15	2026-07-09

Product code LON

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)