FDA Medical Device Recalls (openFDA)
Biomerieux Inc: VITEK 2 AST-N447 TEST KIT Product reference 424620
- Recall number
- Z-2715-2026
- Recalling firm
- Biomerieux Inc
- Product
- VITEK 2 AST-N447 TEST KIT Product reference 424620
- Status
- Open, Classified
- Initiated
- 2026-06-04
- Posted
- 2026-07-09
- Terminated
- not on file
- 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, customer should notify downstream users/accounts.
- Quantity
- 45,900 cards
- Distribution
- International distribution to the countries of Belgium and the Netherlands.
- Lot, serial or model codes
- Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LON
- Firm FEI
- 1950204
- Firm city
- Hazelwood
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28