Reported Dec 3, 2025 · Ongoing
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
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, IVD
- REF423742 (30 test kit)
- Lot codes and dates
- UDI00815381020529 /Lot # 2649724 Expanded Lot#: 1471725
- Amount recalled
- 97 Kits (2,910 pouches)
Where it was sold
Why it was recalled
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
This product could cause temporary or reversible health problems — stop using it.
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