Biofire Diagnostics, LLC
20 devices · 670 adverse event reports · 22 deaths reported · 17 devices named in recalls
Counts reflect reports that name each device's exact identifier. Larger companies sell more devices, so totals should not be read as a safety ranking.
- BioFire® Blood Culture Identification 2 (BCID2) Panel RFIT-ASY-0147Gram-Positive Bacteria And Their Resistance Markers6 recalls6 deaths555 reports
- FilmArray® Gastrointestinal (GI) Panel RFIT-ASY-0116Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System6 recalls2 deaths24 reports
- FilmArray® Pneumonia Panel (Pneumo) RFIT-ASY-0144Respiratory Panel5 recalls7 reports
- FilmArray® Pneumonia Panel plus (Pneumoplus) RFIT-ASY-0143Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System3 recalls3 deaths4 reports
- BioFire® Respiratory Panel 2.1 423742Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents3 recalls4 reports
- BioFire® Respiratory Panel 2.1 EUA 423738Reagents, 2019-Novel Coronavirus Nucleic Acid3 recalls0 reports
- FilmArray® BCID Panel RFIT-ASY-0126Real Time Nucleic Acid Amplification System2 recalls2 deaths4 reports
- FilmArray® BCID Panel RFIT-ASY-0127Real Time Nucleic Acid Amplification System2 recalls1 death1 report
- FilmArray® Pneumonia Panel (Pneumo) RFIT-ASY-0145Respiratory Panel2 recalls0 reports
- FilmArray® Torch Module HTFA-SUB-0103Instrumentation For Clinical Multiplex Test Systems1 recall25 reports
- BioFire® Joint Infection (JI) Panel RFIT-ASY-0138Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System1 recall6 reports
- FilmArray® Torch System Base HTFA-ASY-0104Instrumentation For Clinical Multiplex Test Systems1 recall4 reports
- FilmArray® 2.0 Instrument FLM2-ASY-0001Instrumentation For Clinical Multiplex Test Systems1 recall3 reports
- FilmArray® Gastrointestinal (GI) Panel RFIT-ASY-0104Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System1 recall0 reports
- BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel 423485Bordetella Pertussis Dna Assay System1 recall0 reports
- FilmArray® 2.0 Instrument FLM2-ASY-0001-WInstrumentation For Clinical Multiplex Test Systems1 recall0 reports
- FilmArray® Torch Module HTFA-ASY-0003-WInstrumentation For Clinical Multiplex Test Systems1 recall0 reports
- FilmArray® Meningitis/Encephalitis (ME) Panel RFIT-ASY-0118Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System6 deaths30 reports
- FilmArray® Meningitis/Encephalitis (ME) Panel RFIT-ASY-0119Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System2 deaths2 reports
- BioFire® Respiratory Panel 2.1-EZ EUA, 30 Tests 423883Reagents, 2019-Novel Coronavirus Nucleic Acid1 report