BEUDAMED
    212 results · 63ms · Sources: EU EUDAMED, US FDA

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    COBAS TAQMAN ANALYZER

    FDA Adverse Event
    Malfunction ·ROCHE INSTRUMENT CENTER AG·Product code JJF·May 13, 2004

    ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COBAS AMPLICOR ANALYZER

    FDA Adverse Event
    Malfunction ·ROCHE INSTRUMENT CTR·Product code JJE·April 30, 2004

    Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN; Catalog no. 04522320190. Product is an in vitro diagnostic.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JIX·September 15, 2008

    Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH, Assembled for and Distributed by: Roche Diagnostics Corporation, Indianapolis, IN. For the quantitative determination of Cyclosporine in whole blood, using automated clinical analyzers as an aid in management of therapy in kidney, liver, and heart transplants

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code MKW·August 13, 2010

    AIA-360

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code KHO·February 14, 2019

    ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roche Diagnostics Corporation Indianapolis, IN.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code LAN·February 5, 2010

    Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis, IN 46250.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JJY·December 4, 2007

    902 HITACHI

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORPORATION·Product code JJE·June 8, 2010

    ELECSYS 2010 RACK

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORPORATION·Product code JJE·June 11, 2010

    *

    FDA Adverse Event
    ROCHE DIAGNOSTICS CORPORATION·Product code JJF·December 9, 2014

    ACCUCHEK

    FDA Adverse Event
    Other ·ROCHE DIAGNOSTICS CORPORATION·Product code CFR·October 21, 2003

    COBAS INTEGRA CALCIUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORPORATION·Product code CIC·October 21, 2010

    COBAS INTEGRA CALCIUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORPORATION·Product code CIC·October 13, 2010

    ANALYTICAL E MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORPORATION·Product code JJE·October 22, 2010

    COBAS INTEGRA CALCIUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORPORATION·Product code CIC·October 29, 2010

    ANALYTICAL E MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORPORATION·Product code JJE·October 28, 2010

    ELECSYS 2010 RACK

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORPORATION·Product code MMI·October 28, 2010

    COBAS INTEGRA CALCIUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORPORATION·Product code CIC·October 4, 2010