Official recall notice
FDA DeviceClass IINotable
FDA Recall: BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed
- Recall date
- 2026-08-19
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Due to increase in false negative results
Recommended action
What to do
2,370 pouches (79 kits)
Product description
Due to increase in false negative results