BioFire Respiratory Panel 2 recalled over fire hazard
- Recall date
- April 30, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- BioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
- Recall number
- Z-1877-2025
- FDA classification
- Class II
- Brand / firm
- BioFire Diagnostics, LLC
- Sold / distributed
- International distribution in the country of Singapore.
Why it was recalled
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
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 plus Kit, REF: 423740, For Filmarray systems
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