Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 recall (BioFire Diagnostics, LLC)
Medical deviceClass IIOngoing
Summary: BioFire Diagnostics, LLC is recalling Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485. Reason: Respiratory/sore throat panel test may result in false negative results and control failures.
What is being recalled
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Why
Respiratory/sore throat panel test may result in false negative results and control failures.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of MS, TX MN, VA. (states named: Minnesota, Mississippi, Texas, Virginia)
How to tell if yours is affected
Lot Number: 2215125/UDI: 00815381020390
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2081-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 1, 2026 |
| Reported | May 13, 2026 |
| Company | BioFire Diagnostics, LLC |
| Company location | Salt Lake City, UT, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 2400 pouches |
More recalls from BioFire Diagnostics, LLC · all medical device recalls · recalls from April 2026