BEUDAMED
    FDA Recall Terminated

    Roche CoaguChek XS System, CoaguChek XS Plus Care Kit, Roche Diagnostics, Indianapolis, IN; Model Number 05021537001. CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication.

    Recall: Z-2004-2009 · Initiated July 22, 2009

    Recall

    Recall Number
    Z-2004-2009
    Event Number
    52724
    Firm
    Roche Diagnostics Operations, inc.
    FEI Number
    1823260
    Product Code
    GJS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 22, 2009
    Posted
    September 3, 2009
    Terminated
    April 27, 2011
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche CoaguChek XS System, CoaguChek XS Plus Care Kit, Roche Diagnostics, Indianapolis, IN; Model Number 05021537001. CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication.

    Reason

    The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.

    Action

    Roche Diagnostics Operations, Inc. notified Consignees by letter dated July 22, 2009 informing them of the problem and instructing them to use revised cleaning procedures. For further questions, contact Roche Diagnostics Operations, Inc. at 1-317-521-3194.

    Distribution

    Worldwide Distribution

    Quantity

    1,327 in US