FDAFDA · Food and drugs·Recall number Z-2936-2026
BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
Published August 19, 2026 · Recall initiated: June 24, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to increase in false negative results
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- BioFire Diagnostics, LLC
- Distributor
- U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.
- Lot
- Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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