BEUDAMED
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    DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·December 19, 2012

    DataCare POC  is an information management system that provides data management functionality for managing point-of -care testing data.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·December 19, 2012

    1047429-2015-00003

    FDA Adverse Event
    October 15, 2015

    ADVIA AUTOSLIDE SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code KPA·July 7, 2014

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD·Product code MMI·March 8, 2011

    ID NOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 5, 2020

    ELECSYS ANTI-HBC IGM ASSAY

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS GMBH·Product code LOM·December 4, 2024

    ELECSYS ANTI-HBC IGM ASSAY

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS GMBH·Product code LOM·December 4, 2024

    ID NOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 5, 2020

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·December 16, 2021

    SYRINGE SINGLE 200CC INJECTOR SY

    FDA Adverse Event
    Malfunction ·BRACCO INJENEERING S.A.·Product code DXT·December 6, 2024

    SYRINGE SINGLE 200CC INJECTOR SY

    FDA Adverse Event
    Malfunction ·BRACCO INJENEERING S.A.·Product code DXT·December 6, 2024

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code JGS·May 25, 2012

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code MMI·May 25, 2012

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QYT·October 15, 2025

    ADVIA 120 WITH AUTOSAMPLER

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code GKZ·September 9, 2014

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 27, 2023

    ID NOW COVID-19 2.0 TEST KIT 24T JAPAN

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·May 23, 2023

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 27, 2023

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 27, 2023