- Recalling firm
- BioFire Diagnostics, LLC
- Reason for recall
- Respiratory/sore throat panel test may result in false negative results and control failures.
- Affected products (lot / model / serial)
- Lot Number: 2215125/UDI: 00815381020390
- Units affected
- 2400 pouches
- Distribution pattern
- US Nationwide distribution in the states of MS, TX MN, VA.
- Firm location
- Salt Lake City, UT, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2081-2026
- Recall initiated
- April 1, 2026
- FDA classification date
- May 6, 2026
- FDA report date
- May 13, 2026
- FDA event ID
- 98719
- Last updated on HTM Vibe
- July 24, 2026