Device recall
BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
- Recall number
- Z-2936-2026
- Event id
- 99261
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- BioFire Diagnostics, LLC
- Report date
- Aug 19, 2026
- Initiated
- Jun 24, 2026
- Center classification date
- Aug 12, 2026
- Reason
- Due to increase in false negative results
- Quantity
- 2,370 pouches (79 kits)
- Code info
- Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125
- Distribution
- U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Salt Lake City, UT, United States