Brand
BioFire Diagnostics, LLC
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for BioFire Diagnostics, LLC 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.
- 2025-06-04FDA-DeviceClass IIBioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
- 2025-04-16FDA-DeviceClass IIFilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
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