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BioFire Diagnostics
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for BioFire Diagnostics and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-12-03FDA-DeviceClass IIBioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
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