BEUDAMED
    FDA Recall Terminated

    ACCU-CHEK Advantage Complete Diabetes Monitoring Kit, Cat. No. 860. Ref. no. 080086000 with meter model number 870; Ref. no. 03002531001 with meter model number 33304510; Ref. no. 03002531001 with meter model number 2138930; Ref. no. 03002531001 with meter model number 2138930.

    Recall: Z-1355-06 · Initiated June 22, 2006

    Recall

    Recall Number
    Z-1355-06
    Event Number
    35022
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 22, 2006
    Posted
    August 5, 2006
    Terminated
    April 7, 2008
    Address
    9115 Hague Rd, Indianapolis, IN, 46250-0416

    Description

    ACCU-CHEK Advantage Complete Diabetes Monitoring Kit, Cat. No. 860. Ref. no. 080086000 with meter model number 870; Ref. no. 03002531001 with meter model number 33304510; Ref. no. 03002531001 with meter model number 2138930; Ref. no. 03002531001 with meter model number 2138930.

    Reason

    The meter gives a strip error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a strip error and the manual only instructs the user to retest with a new strip using a larger drop of blood.

    Action

    A recall notification letter dated April 24, 2006 was sent to each customer alerting them to the fact that this error code has a dual meaning. New software will be installed in all meters when it becomes available.

    Distribution

    Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands.

    Quantity

    55,189 meters (for all Recalls Z-1354-1371-06)