BEUDAMED
    FDA Recall Terminated

    CoaguChek Pro DM meter; catalog # 1894048 and 1893211.

    Recall: Z-0813-03 · Initiated March 12, 2003

    Recall

    Recall Number
    Z-0813-03
    Event Number
    25574
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    JPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 12, 2003
    Posted
    May 14, 2003
    Terminated
    February 3, 2005
    Address
    9115 Hague Road, Indianapolis, IN, 46250-0457

    Description

    CoaguChek Pro DM meter; catalog # 1894048 and 1893211.

    Reason

    High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.

    Action

    Urgent Product Removal letters dated 3/12/03 were sent to all customers. Distributors were asked to conduct a recall from their customers. Replacement meters are not currently available from Roche. Roche will temporarily provide a CoaguChek S system to run PT samples and will reimburse for APTT and ACT tests that are sent to an accredited outside laboratory.

    Distribution

    United States

    Quantity

    1322