Official recall notice
FDA DeviceClass IINotable
BIOFIRE Respiratory Panel 2.1 Recall (Aug 2026)
Product: BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
- Recall date
- 2026-08-19
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Due to increase in false negative results
Product description
Due to increase in false negative results
Affected products
Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125