- 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.
- Affected products (lot / model / serial)
- Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.
- Units affected
- 45,900 cards
- Distribution pattern
- International distribution to the countries of Belgium and the Netherlands.
- Firm location
- Hazelwood, MO, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2715-2026
- Recall initiated
- June 4, 2026
- FDA classification date
- July 9, 2026
- FDA report date
- July 15, 2026
- FDA event ID
- 99213
- Last updated on HTM Vibe
- July 23, 2026