BEUDAMED
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    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

    Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JQP·September 22, 2015

    Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JJE·November 19, 2012

    Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be use with single-use, auto-disabling lancing devices.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code LFR·February 11, 2016