The FDA has posted 5 enforcement recalls from BioFire Diagnostics, LLC since 2025, none of them Class I (most serious). Most recent report: May 13, 2026.
Contamination to in-vitro diagnostic test may result in false positives.
Respiratory/sore throat panel test may result in false negative results and control failures.
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
Firm name as filed with the FDA: “BioFire Diagnostics, LLC”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.