BEUDAMED
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    BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QDS·June 10, 2024

    BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QDS·June 10, 2024

    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

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PEN·June 19, 2024

    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.

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PCH·May 16, 2024