Device product
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Z-2081-2026
Product summary
- Event
- Event 98719
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2400 pouches
- Official record key
device-enforcement:Z-2081-2026
Official wording
Reason: Respiratory/sore throat panel test may result in false negative results and control failures.
Code information: Lot Number: 2215125/UDI: 00815381020390
Distribution pattern: US Nationwide distribution in the states of MS, TX MN, VA.
Derived failure modes
-
Unknown
Respiratory/sore throat panel test may result in false negative results and control failures.