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    FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code OCC·August 7, 2024

    FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code NSU·August 7, 2024

    FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PCH·April 25, 2023

    Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS 2. ASY-16825 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.1 SYSTEMS 3. ASY-17219 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.10.0 SYSTEMS 4. ASY-17220 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.1.0 SYSTEMS 5. ASY-17221 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.0 SYSTEMS 6. ASY-17222 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.0 SYSTEMS 7. 3DM-LIC-SW-UP-V2.3 DIMENSIONS SOFTWARE 2.3 (3DIMENSIONS) 8. SDM-LIC-SW-UP-V1.12 DIMENSION SOFTWARE 1.12 (SELENIA DIMENSIONS)

    FDA Recall
    Open, Classified ·Hologic Inc·Product code OTE·August 19, 2024

    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.

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PCH·January 26, 2024

    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

    In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PEN·February 1, 2023

    In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PCH·February 1, 2023

    BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QSN·April 22, 2026

    FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system.

    FDA Recall
    Open, Classified ·Biofire Defense·Product code PRD·July 10, 2025

    FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PCH·March 8, 2023

    FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QBH·December 14, 2023

    FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QBH·May 8, 2023

    FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or approved IVD BioFire FilmArray Panels. Additional Part/Reference Numbers as part of the system: - HTFA-ASY-0102: BIOFIRE TORCH Duplex. This is a plastic component that covers the BIOFIRE TORCH Modules. The BIOFIRE TORCH Duplex is only necessary if the system includes more than two modules. - HFTA-SUB-0103: BIOFIRE TORCH Module. The BIOFIRE reagent pouches are inserted into the modules.

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code NSU·October 17, 2023

    FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QDS·December 14, 2023

    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code JWH·December 1, 2023

    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code JWH·December 1, 2023

    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code JWH·December 1, 2023

    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