BEUDAMED
    FDA Enforcement Class II Terminated

    CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.

    Recall: Z-1584-2013 · Reported July 3, 2013

    Enforcement

    Recall Number
    Z-1584-2013
    Event ID
    65246
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2013
    Initiation Date
    May 16, 2013
    Classification Date
    June 24, 2013
    Termination Date
    April 16, 2014
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025, United States

    Description

    CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.

    Reason

    Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed.

    Code Info

    Model/Catalog/Part Number: 04837975001 and 04625412160

    Distribution

    Nationwide Distribution

    Quantity

    86553 meters