BEUDAMED
    FDA Recall Terminated

    TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    Recall: Z-0723-04 · Initiated February 16, 2004

    Recall

    Recall Number
    Z-0723-04
    Event Number
    28342
    Firm
    Abbott Laboratories HPD/ADD/GPRD
    FEI Number
    1415939
    Product Code
    JFT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 16, 2004
    Posted
    July 20, 2004
    Terminated
    July 26, 2004
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    Reason

    The package inserts contain incorrect control values for the urinary free cortisol extraction procedure.

    Action

    Field Correction recall by Important Product Information letter dated 2/16/04, sent via e-mail to the Abbott international subsidiaries on the same date for notification of all of their accounts receiving the Cortisol reagents and X Systems Cortisol controls since March 2002. The accounts were informed of the incorrect values for the Cortisol controls, when using the urinary free cortisol extraction procedure, listed in the package inserts of the reagent kits as well as the controls. The letters contained a table listing the incorrect values and the correct values for each of the products, and the users were instructed to use the corrected values as provided in the letter.

    Distribution

    There was no domestic distribution. The product was distributed internationally through Abbott subsidiaries in Canada, United Kingdom, Japan, Singapore, Hong Kong, Korea, Australia, New Zealand, Honduras, Costa Rica, Panama, Dominican Republic, Germany and Pakistan.

    Quantity

    1,487 kits