BioFire Diagnostics, LLC recalls

6 recalls.

• Generic Name: BioFire¿ Joint Infection recall (BioFire Diagnostics, LLC)
  Medical deviceClass IIReported October 21, 2026 · Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
• Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel... recall (BioFire Diagnostics, LLC)
  Medical deviceClass IIReported October 21, 2026 · Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
• Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel ... recall (BioFire Diagnostics, LLC)
  Medical deviceClass IIReported October 21, 2026 · Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
• BIOFIRE Respiratory Panel 2.1 recall (BioFire Diagnostics, LLC)
  Medical deviceClass IIReported August 19, 2026 · Due to increase in false negative results
• Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 recall (BioFire Diagnostics, LLC)
  Medical deviceClass IIReported May 13, 2026 · Respiratory/sore throat panel test may result in false negative results and control failures.
• BioFire Joint Infection recall (BioFire Diagnostics, LLC)
  Medical deviceClass IIReported May 13, 2026 · Contamination to in-vitro diagnostic test may result in false positives.