Reported Aug 19, 2026 · Ongoing · Updated Sep 16, 2026
BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in…
BioFire Diagnostics, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioFire Diagnostics, LLC · 515 S Colorow Dr · Salt Lake City, UT · 84108-1248
Is this the product you have?
- BIOFIRE Respiratory Panel 2.1 (RP2.1)
- REF 423742 UDI code00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
- Lot codes and dates
- Part Number423742
- UDI-DI code00815381020529
- Pouch Lot3VLB25
- Kit Lot1872125
- Amount recalled
- 2,370 pouches (79 kits)
Where it was sold
Why it was recalled
Due to increase in false negative results
This product could cause temporary or reversible health problems — stop using it.
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