Reported May 13, 2026 · Ongoing
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
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 Spotfire
- Respiratory/Sore Throat Panel REF423485
- Lot codes and dates
- Lot Number2215125/UDI: 00815381020390
- Amount recalled
- 2400 pouches
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Respiratory/sore throat panel test may result in false negative results and control failures.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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