BEUDAMED
    FDA Recall 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 · Initiated March 6, 2013

    Recall

    Recall Number
    Z-1113-2013
    Event Number
    64460
    Firm
    Roche Diagnostics Operations, Inc.
    FEI Number
    1823260
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 6, 2013
    Posted
    April 15, 2013
    Terminated
    January 10, 2018
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    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.

    Action

    Consignees of both devices were notified by Urgent Medical Device Correction letters sent via UPS Ground (receipt required) beginning 3/06/2013. The notice contained recommendation not to use EAN-13 barcode system and ensure barcodes used meet quality standards; use operator and patient lists (downloaded from a data manager) in order to check any decoded identification against the respective list. The notice directed forwarding of the notice if the product was further distributed. Customers were asked to complete the attached fax form. Contact the Customer Care Service Center, 24 hours a day, seven days a week at 1-800-440-3638 for Accu check questions and 1-800-428-4674 for CoaguChek questions about the information contained in this UMDC.

    Distribution

    Nationwide Distribution.

    Quantity

    Both devices 4467