BEUDAMED
    FDA Recall Terminated

    ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter.

    Recall: Z-1370-05 · Initiated June 7, 2005

    Recall

    Recall Number
    Z-1370-05
    Event Number
    32100
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 7, 2005
    Posted
    August 13, 2005
    Terminated
    July 2, 2007
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter.

    Reason

    The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards, and held upwards, while the meter is waiting for the sample.

    Action

    Recall letters dated 6/7/05 were sent to all customers. Distributors were requested to send a copy of the notification to all customers of test strips used with the product. Users are instructed to never operate the meter without the optics cover in place, and this information will be included in test strip boxes.

    Distribution

    Nationwide.

    Quantity

    2490