Biofire Spotfire Respiratory/Sore Throat Panel REF recalled over fire hazard
- Recall date
- April 1, 2026
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- BioFire Diagnostics, LLC recalls Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
- Recall number
- Z-2081-2026
- FDA classification
- Class II
- Brand / firm
- BioFire Diagnostics, LLC
- Sold / distributed
- US Nationwide distribution in the states of MS, TX MN, VA.
Why it was recalled
Respiratory/sore throat panel test may result in false negative results and control failures.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
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