BioFire Diagnostics, LLC recalls

All BioFire Diagnostics, LLC recalls we track from FDA, CPSC and NHTSA data. Categories: medical devices (6).

6 recalls published between April 16, 2025 and August 19, 2026. Most common issues: microbial contamination (1).

• BIOFIRE Respiratory Panel 2.1 (RP2.1) recall
  FDA August 19, 2026 · BioFire Diagnostics, LLC · Class II
• Biofire Spotfire Respiratory/Sore Throat Panel recall
  FDA May 13, 2026 · BioFire Diagnostics, LLC · Class II
• BioFire Joint Infection (JI) Panel recall
  FDA May 13, 2026 · BioFire Diagnostics, LLC · Class II
• BioFire Respiratory Panel 2.1, IVD recall
  FDA December 3, 2025 · BioFire Diagnostics, LLC · Class II
• BioFire Respiratory Panel 2.1 plus Kit recall
  FDA June 4, 2025 · BioFire Diagnostics, LLC · Class II
• FilmArra Pneumonia Panel plus (Pneumoplus) recall
  FDA April 16, 2025 · BioFire Diagnostics, LLC · Class II