Official recall notice
FDA DeviceClass IINotable
FDA Recall: Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
- Recall date
- 2026-05-13
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Respiratory/sore throat panel test may result in false negative results and control failures.
Recommended action
What to do
2400 pouches
Product description
Respiratory/sore throat panel test may result in false negative results and control failures.