TemporaryFDAOngoing
Can cause harm that is usually temporary.
BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
Check the device or its packaging for
Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125
- Why
- Due to increase in false negative results
- Distributed
- U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.
- Company
- BioFire Diagnostics, LLC
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2936-2026 · retrieved 12 August 2026
Read the official notice