BEUDAMED
    FDA Recall Terminated

    ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 test kit) and 5C63-21(40 test kit); Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA

    Recall: Z-1048-04 · Initiated June 11, 2004

    Recall

    Recall Number
    Z-1048-04
    Event Number
    29352
    Firm
    Abbott Laboratories HPD/ADD/GPRD
    FEI Number
    1415939
    Product Code
    GTZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 11, 2004
    Posted
    July 20, 2004
    Terminated
    October 5, 2004
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 test kit) and 5C63-21(40 test kit); Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA

    Reason

    False Positive results may be obtained with the identified lots when using a negative patient sample or a negative control.

    Action

    A Device Recall Letter was sent to customers that received the affected product lots on 6/11/04 via Federal Express Priority. The accounts were informed of the false positive readings, and were requested to destroy any affected inventory of the recalled lots.

    Distribution

    The product was not distributed in the U.S. The product was distributed internationally through Abbott affiliates in Argentina, Korea, the United kingdom, Japan, Singapore, the Dominican Republic, Canada, Hong Kong, Chile and Germany

    Quantity

    75,368 kits