BioFire Respiratory Panel 2 recalled over fire hazard
- Recall date
- October 22, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- BioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
- Recall number
- Z-0602-2026
- FDA classification
- Class II
- Brand / firm
- BioFire Diagnostics, LLC
- Sold / distributed
- US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None
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.
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 Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
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