Gastrointestinal pathogen panel multiplex nucleic acid-based assay system

FDA product code PCH · Class 2 · 7 devices · 311 reports · 2 deaths reported · 7 devices named in recalls

• FilmArray® Gastrointestinal (GI) Panel RFIT-ASY-0116

  Biofire Diagnostics, LLC · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
  6 recalls2 deaths24 reports
• BD MAX™ Enteric Bacterial Panel 442963

  Becton, Dickinson And Company · Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
  2 recalls102 reports
• BD MAX™ Extended Enteric Bacterial Panel 443812

  Becton, Dickinson And Company · Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
  1 recall114 reports
• BD MAX™ Enteric Parasite Panel 442960

  Becton, Dickinson And Company · Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
  1 recall70 reports
• Enteric Pathogens (EP) Stool Sample Preparation Kit 30-002-023

  Luminex Corporation · Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
  2 recalls1 report
• FilmArray® Gastrointestinal (GI) Panel RFIT-ASY-0104

  Biofire Diagnostics, LLC · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
  1 recall0 reports
• xTAG® Gastrointestinal Pathogen Panel (GPP) I032C0316

  Luminex Molecular Diagnostics, Inc · Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
  1 recall0 reports