BEUDAMED
    FDA Recall Terminated

    ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064

    Recall: Z-0353-04 · Initiated December 15, 2003

    Recall

    Recall Number
    Z-0353-04
    Event Number
    27977
    Firm
    Abbott Laboratories HPD/ADD/GPRD
    FEI Number
    1415939
    Product Code
    CEC--
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 15, 2003
    Posted
    July 20, 2004
    Terminated
    July 22, 2004
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064

    Reason

    The calibrator lots may yield Free T4 values that are depressed.

    Action

    Architect Free T4 Calibrator kits were recalled by letter dated 12/15/03. The accounts were informed of the out of range control values, and the potential for depressed patient values with the kits, and were requested to discontinue use and destroy the affected lots of product.

    Distribution

    Nationwide and internationally to Abbott subsidiaries in Brazil, Canada, Germany, Japan, Singapore, Hong Kong, Thailand, Korea, Australia, Colombia, New Zealand, Venezuela and Taiwan.

    Quantity

    1,364 kits