BEUDAMED
    FDA Recall Terminated

    CoaguChek PT test strips, sold in 12 pack.

    Recall: Z-0720-03 · Initiated February 20, 2003

    Recall

    Recall Number
    Z-0720-03
    Event Number
    25795
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    JPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 20, 2003
    Posted
    April 10, 2003
    Terminated
    November 10, 2003
    Address
    9115 Hague Road, Indianapolis, IN, 46250-0457

    Description

    CoaguChek PT test strips, sold in 12 pack.

    Reason

    Discrepancy between INR and the % Quick displayed on the meter.

    Action

    Customers in Germany were notified of the recall, and asked to return this lot of product. While the product is sold in many countries, Germany is the only country affected, since their results are the only ones reported as % Quick.

    Distribution

    Germany

    Quantity

    11412 containers