BioFire Diagnostics, LLC

BioFire Diagnostics, LLC: 3 recalls listed since May 2026 across FDA.

By year

20263

By agency

FDA3

By category

Medical Device3

All recalls (3)

FDA•Aug 12, 2026MODERATE
BIOFIRE Respiratory Panel 2.1
BioFire recalls BIOFIRE Respiratory Panel 2.1 over increased false negatives.
FDA•May 6, 2026MODERATE
Biofire Spotfire Respiratory/Sore Throat Panel
BioFire is recalling the Spotfire Respiratory/Sore Throat Panel due to the risk of false negative results and control failures.
FDA•May 6, 2026MODERATE
BioFire Joint Infection Panel
BioFire is recalling the Joint Infection (JI) Panel due to contamination that may cause false positive test results.