FDA Recalls BioFire Pneumonia Diagnostic Test Kits for Control Failures
BioFire Diagnostics recalls BIOFIRE FILMARRAY Pneumonia Panel plus test kits due to manufacturing defects that could lead to control failures and delayed test results. The affected kits were distributed in multiple US states and countries worldwide.
- Product
- BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
- Category
- Medical Device
- Distribution
- Distributed nationwide