- Recalling firm
- BioFire Diagnostics, LLC
- Reason for recall
- Due to increase in false negative results
- Affected products (lot / model / serial)
- Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125
- Units affected
- 2,370 pouches (79 kits)
- Distribution pattern
- U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.
- Firm location
- Salt Lake City, UT, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2936-2026
- Recall initiated
- June 24, 2026
- FDA classification date
- August 12, 2026
- FDA report date
- August 19, 2026
- FDA event ID
- 99261
- Last updated on HTM Vibe
- August 26, 2026