BEUDAMED
    FDA Enforcement Class II Terminated

    ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).

    Recall: Z-1113-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1113-2013
    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

    ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).

    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.

    Code Info

    part number 05060311001, 05060303001

    Distribution

    Nationwide Distribution.

    Quantity

    Both devices 4467