- Recalling firm
- BioFire Diagnostics, LLC
- Reason for recall
- Contamination to in-vitro diagnostic test may result in false positives.
- Affected products (lot / model / serial)
- Lot #s:0883425,0878825/DI: 00815381020192
- Units affected
- 106 kits (3,180 test)
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of TX, NC, UT, MD and the countries of France, Italy, Germany, Spain, Belgium, Switzerland, United Kingdom, Netherlands, Poland, Austria, India, Finland, Czech Republic, Egypt, Lebanon, Morocco, Slovenia, Romania, Dominican Republic, Serbia.
- 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-2067-2026
- Recall initiated
- April 22, 2026
- FDA classification date
- May 6, 2026
- FDA report date
- May 13, 2026
- FDA event ID
- 98776
- Last updated on HTM Vibe
- July 23, 2026