FDA DevicesClass II
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Published: May 13, 2026Recall ID: Z-2081-2026Category: devicesCountry: US
Reason for Recall / Hazard
Respiratory/sore throat panel test may result in false negative results and control failures.
Product Description & Identification
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Affected Products
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Additional Source Details
| Field | Value |
|---|---|
| City | Salt Lake City |
| State | UT |
| Event id | 98719 |
| Address 1 | 515 S Colorow Dr |
| Code info | Lot Number: 2215125/UDI: 00815381020390 |
| Postal code | 84108-1248 |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 2400 pouches |
| Reason for recall | Respiratory/sore throat panel test may result in false negative results and control failures. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260401 |
| Initial firm notification | |
| Center classification date | 20260506 |
Overview
- Recalling FirmBioFire Diagnostics, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of MS, TX MN, VA.