BEUDAMED
    FDA Recall Terminated

    ACCU-CHEK Compact Meter; catalog number 3183572.

    Recall: Z-0976-05 · Initiated May 18, 2005

    Recall

    Recall Number
    Z-0976-05
    Event Number
    31949
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 18, 2005
    Posted
    July 12, 2005
    Terminated
    December 12, 2005
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    ACCU-CHEK Compact Meter; catalog number 3183572.

    Reason

    The meter may self-start without a sample having been applied and report erroneous results without an error message if the nose cover is not properly snapped in place and the undosed test strip is bent upwards while the meter is waiting for the sample, or if excess control solution or blood has been applied to the test strip.

    Action

    A recall letter dated 5/18/05 was sent to health care professionals informing them of the problem and reqeusting them to provide a letter to their patients alerting them to the issue and how to avoid it. A notice of the problem will be placed in all packages of strips in the future.

    Distribution

    Nationwide.