BEUDAMED
    230 results · 39ms · Sources: EU EUDAMED, US FDA

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    VIDAS® LYME IGM (LYM)

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX SA·Product code LSR·July 19, 2023

    VIDAS® LYME IGM (LYM)

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX SA·Product code LSR·July 19, 2023

    CD RUBY

    FDA Adverse Event
    Other ·ABBOTT DIAGNOSTICS DIVISION/CELL DYN·Product code GKZ·January 8, 2008

    CELL-DYN 1800 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·May 15, 2009

    ALINIQ AMS

    FDA Adverse Event
    Malfunction ·ABBOTT SRL·Product code JQP·June 13, 2025

    ALINITY HQ ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code GKZ·February 10, 2025

    ALINITY HQ PROCESSING MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code GKZ·July 12, 2024

    RFS STYLET, 6F, 12CM

    FDA Adverse Event
    Injury ·COVIDIEN·Product code GEI·April 25, 2017

    ALINITY HQ PROCESSING MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code GKZ·May 8, 2024

    ALINITY HS SLIDE MAKER STAINER MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code KPA·August 27, 2024

    CELL-DYN RUBY ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·September 28, 2016

    CELL-DYN RUBY

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code GKZ·March 31, 2025

    CELL-DYN SAPPHIRE ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·July 29, 2015

    VIDAS Lyme IgG II (LYM), REF 417401

    FDA Recall
    Open, Classified ·bioMerieux, Inc.·Product code LSR·September 22, 2021

    VIDAS Lyme IgM II (LYM), REF 416436

    FDA Recall
    Open, Classified ·bioMerieux, Inc.·Product code LSR·September 22, 2021

    INFANT RESCUSITATION BAG

    FDA Adverse Event
    Malfunction ·MERCURY MEDICAL·Product code LYM·July 29, 1994

    PEGGY PREEMIE

    FDA Adverse Event
    Other ·LAERDAL MEDICAL CORP.·Product code LYM·June 11, 1998

    MERCURY MEDICAL

    FDA Adverse Event
    Malfunction ·MERCURY MEDICAL·Product code LYM·October 6, 2004

    VIDAS Lyme IgM II (LYM), REF 416436

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    VIDAS Lyme IgG II (LYM), REF 417401

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022