BEUDAMED
    FDA Recall Terminated

    ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles and bottles of Conjugate; 400 Test Kit-list number 2K25-20 (4 x 100 tests) and 100 Test Kit-list number 2K25-25 (1 x 100 tests); Abbott Laboratories, Abbott Park, IL 60064-3500

    Recall: Z-0728-2007 · Initiated February 19, 2007

    Recall

    Recall Number
    Z-0728-2007
    Event Number
    37446
    Firm
    Abbott Laboratories
    FEI Number
    1415939
    Product Code
    CHP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 19, 2007
    Posted
    April 7, 2007
    Terminated
    January 9, 2008
    Address
    100 Abbott Park Rd, Abbott Park, IL, 60064-3502

    Description

    ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles and bottles of Conjugate; 400 Test Kit-list number 2K25-20 (4 x 100 tests) and 100 Test Kit-list number 2K25-25 (1 x 100 tests); Abbott Laboratories, Abbott Park, IL 60064-3500

    Reason

    A small number of reagent kits were incorrectly configured. The affected kits contain either two bottles of conjugate or two bottles of assay diluent instead of one bottle of each.

    Action

    Abbott initiated a field correction recall by letter dated 2/19/07 to all customers receiving the affected reagent. The accounts were informed of the incorrectly configured reagent kits. The accounts were requested to assess the inventory for the affected lots of reagents, inspect each kit and destroy any kits incorrectly configured, recording the number of kits inspected and the number of kits discarded on the customer reply form and faxing it to Abbott by 3/2/07, indicating that the letter was received and understood. Replacement kits will be issued for the number of kits destroyed, as indicated on the reply sheet. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688.

    Distribution

    Worldwide distribution including U.S.A., Puerto Rico, Canada, Mexico, Venezuela, Chile, Uruguay, Argentina, Brazil, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, New Zealand and Panama.

    Quantity

    1,944 kits