BEUDAMED
    FDA Recall Terminated

    ACCU-CHEK Inform meter; catalog No. 3035123.

    Recall: Z-0372-05 · Initiated November 19, 2004

    Recall

    Recall Number
    Z-0372-05
    Event Number
    30462
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 19, 2004
    Posted
    December 28, 2004
    Terminated
    June 7, 2005
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    ACCU-CHEK Inform meter; catalog No. 3035123.

    Reason

    A firmware bug may allow test results from other systems, recorded into the INFORM system via the OTE functionality, to be reversed from positive to negative, and vice versa.

    Action

    Consignees were notified via a letter dated 11/19/04, which instructed them to discontinue using the OTE functionality.

    Distribution

    Nationwide.

    Quantity

    4697