BEUDAMED
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    Biovire, Inc.

    FDA registration
    Biovire, Inc.·4 products·🇺🇸 United States

    BD BACTEC PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 27, 2021

    BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

    FDA Adverse Event
    Malfunction ·BIOFIRE DIAGNOSTICS, LLC·Product code PAM·May 15, 2025

    BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1-PRT-0251

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·December 13, 2023

    ID NOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QJR·January 19, 2022

    BACT/ALERT FA PLUS (PLASTIC) 100 BTLS - 410851

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX, INC.·Product code MDB·August 22, 2024

    BACT/ALERT FA PLUS (PLASTIC) 100 BTLS - 410851

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX, INC.·Product code MDB·August 22, 2024

    BACT/ALERT FA PLUS (PLASTIC) 100 BTLS - 410851

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX, INC.·Product code MDB·August 22, 2024

    BACT/ALERT FA PLUS (PLASTIC) 100 BTLS - 410851

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX, INC.·Product code MDB·August 22, 2024

    BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1-PRT-0251

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

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·October 26, 2023

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·October 26, 2023

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·October 26, 2023

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·October 26, 2023

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·February 9, 2022

    ID NOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH INC.·Product code QJR·February 12, 2021

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 30, 2021

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QJR·February 26, 2022

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QJR·February 26, 2022

    ID NOW COVID 19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·March 18, 2022