BEUDAMED
    136 results · 17ms · Sources: EU EUDAMED, US FDA

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    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

    BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only

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

    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

    In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742

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

    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 Spotfire Respiratory/Sore Throat Panel REF: 423485

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QOF·April 1, 2026

    BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code OCC·April 30, 2025

    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

    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.

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

    FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QDS·February 27, 2025

    BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QOF·October 22, 2025

    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 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

    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

    VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491; h) AST-N401, REF 423643; i) AST-N402, REF 423644; j) AST-N404, REF 423664; k) AST-N802, REF 423706; l) AST-N405, REF 423864; m) AST-N417, REF 423880; n) AST-N408, REF 423924; o) AST-N409, REF 423925; p) AST-N420, REF 424039; q) AST-N423, REF 424042; r) AST-N422, REF 424056; s) AST-N436, REF 424440; t) AST-N809, REF 424703; u) AST-N806, REF 424709; v) AST-N807, REF 424710; w) AST-N808, REF 424711; x) AST-N810, REF 424712; y) AST-N812, REF 424721

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code LON·March 14, 2024

    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

    VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code LON·November 9, 2022

    VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code LFY·November 9, 2022

    ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JWY·November 9, 2022