BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-1998-2011 · Initiated August 13, 2010

    Recall

    Recall Number
    Z-1998-2011
    Event Number
    56636
    Firm
    Roche Diagnostics Operations, Inc.
    FEI Number
    1823260
    Product Code
    MKW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 13, 2010
    Posted
    April 15, 2011
    Terminated
    May 4, 2011
    Address
    9115 Hague Road, Indianapolis, IN, 46256-1025

    Description

    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

    Reason

    The cyclosporine sample pretreatment reagent lot was assigned an incorrect expiration date.

    Action

    Roche Diagnostics Corporation sent an Urgent Medical Device Removal letter dated 8/13/2011, by UPS ( signature required ) to the consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to discontinue use of affected product upon receipt of replacement product. Consignees were instructed to dispose of the product at their facilities. Therefore, no product returns are anticipated. Questions concerning this recall please call (317) 521-3911.

    Distribution

    Nationwide Distribution -- including, IN, NJ, NY, TX, CA, PA, OH, and FL.

    Quantity

    22 kits