BioFire Diagnostics, LLC recalls

7 recalls on record · latest: April 22, 2026

Official U.S. recall history for BioFire Diagnostics, LLC, compiled from official government records.

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BioFire Joint Infection Panel REF: RFIT-ASY-0138 recalled over fire hazard

April 22, 2026 · Medical device recalls Moderate risk Contamination to in-vitro diagnostic test may result in false positives.

Biofire Spotfire Respiratory/Sore Throat Panel REF recalled over fire hazard

April 1, 2026 · Medical device recalls Moderate risk Respiratory/sore throat panel test may result in false negative results and con…

BioFire Respiratory Panel 2 recalled over fire hazard

October 22, 2025 · Medical device recalls Moderate risk Due to unintended movement of pouch chemistry, nucleic acid test may result in…

BioFire Respiratory Panel 2 recalled over fire hazard

April 30, 2025 · Medical device recalls Moderate risk Due to manufacturing error, respiratory panel may result in elevated control fa…

BioFire Diagnostics, LLC recalls FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374

February 27, 2025 · Medical device recalls Moderate risk Increased risk of control failures and false negative test results with multipl…

FILMARRAY TORCH MODULE BOX recalled over Salmonella risk

August 7, 2024 · Medical device recalls Moderate risk Some automated in vitro diagnostic modules and instruments manufactured or serv…

FILMARRAY 2 recalled over Salmonella risk

August 7, 2024 · Medical device recalls Moderate risk Some automated in vitro diagnostic modules and instruments manufactured or serv…