BioFire Diagnostics, LLC recalls
19 federal recalls on file, showing the 3 from the last 12 months. We read every CPSC, FDA, USDA and NHTSA notice for BioFire Diagnostics, LLC and put it in plain English.
Recent recalls
BioFire infection panels recalled for false positive resultsBioFire Diagnostics is recalling specific lots of three infection test panels: the FilmArray Pneumonia Panel, the FilmArray Pneumonia Panel plus, and the BioFire Joint Infection Panel. The lots may be contaminated, which could cause false positive test results. No injuries have been reported, and 9,949 units are listed as affected.
ModerateFDAOct 21, 20263 products
- BioFire Respiratory Panel 2.1 recalled for false negative risk
BioFire Diagnostics is recalling certain lots of its BIOFIRE Respiratory Panel 2.1 (RP2.1) test, a lab test that detects respiratory infections. The company found an increase in false negative results, meaning the test can miss an infection that is actually present. No injuries have been reported.
ModerateFDAAug 19, 2026
- BioFire 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.
FDADec 3, 2025