BioFire Diagnostics, LLC: Medical Device Recalls in 2024

According to to data from the FDA, there were 12 medical device recalls made by BioFire Diagnostics, LLC in 2024. See the details of the recalls below.

You can see similar recalls for other firms.

• BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
• FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
• FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U
• BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE¿ FILMARRAY¿ Systems. The BIOFIRE GI Panel is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection.
• FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
• FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
• BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
• The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.
• FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.
• BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC Standard Aerobic medium BD BACTEC Standard Anaerobic medium The BIOFIRE Blood Culture Identification 2 (BCID2) Panel is a multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
• BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
• BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF PLUS, REF: 410853