BEUDAMED
    FDA Recall Terminated

    Architect Progesterone Reagent Kit; list 6C26-27 (100 tests) and 6C26-22 (400 tests); Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064

    Recall: Z-0782-03 · Initiated March 31, 2003

    Recall

    Recall Number
    Z-0782-03
    Event Number
    25904
    Firm
    Abbott Laboratories HPD/ADD
    FEI Number
    1415939
    Product Code
    JLS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 31, 2003
    Posted
    April 24, 2003
    Terminated
    August 19, 2003
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    Architect Progesterone Reagent Kit; list 6C26-27 (100 tests) and 6C26-22 (400 tests); Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064

    Reason

    Lot gives lower specimen results compared to results generated with other lots.

    Action

    Recalled by telephone calls and follow-up letters dated 3/31/03. The accounts were informed of the depressed patient specimen results, and were requested to discontinue use and destroy any of the three affected lots found in inventory. The accounts were advised to notify physicians of the lower patient results observed with these lots and suggest review of the patient results to determine any impact on patient management.

    Distribution

    Nationwide, Canada, Columbia, England, Japan, Australia, New Zealand and Singapore

    Quantity

    368 kits