BEUDAMED
    FDA Enforcement Class II Terminated

    CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").

    Recall: Z-1114-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1114-2013
    Event ID
    64460
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2013
    Initiation Date
    March 6, 2013
    Classification Date
    April 15, 2013
    Termination Date
    January 10, 2018
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").

    Reason

    Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards. Errors have been confirmed with the EAN 13 barcodes which should not be used for patient or operator identification.

    Code Info

    catalog number 05530199160

    Distribution

    Nationwide Distribution.

    Quantity

    4467 both devices