BioFire Diagnostics, LLC

BioFire Diagnostics, LLC: 4 recalls posted by FDA since May 2026.

By agency

The FilmArray Pneumonia Panel, Pneumonia Panel plus, and BioFire Joint Infection Panel may give false positive results due to contamination.

Moderate riskFDAOct 13, 2026Device defect

The Biofire Respiratory Panel 2.1 may give false negative results.

Moderate riskFDAAug 12, 2026Device defect

The BioFire Joint Infection Panel may be contaminated, causing false positives.

Moderate riskFDAMay 6, 2026Contamination

The Biofire Spotfire Respiratory/Sore Throat Panel may result in false negative results and control failures.

Moderate riskFDAMay 6, 2026Device defect