BEUDAMED
    FDA Recall Terminated

    TDx/TDxFLx Tricyclic Antidepressants Reagent. Distributed under the following label: TDx/TDxFLx Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064.

    Recall: Z-0325-04 · Initiated November 17, 2003

    Recall

    Recall Number
    Z-0325-04
    Event Number
    27843
    Firm
    Abbott Health Products, Inc.
    FEI Number
    2623532
    Product Code
    LFG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 17, 2003
    Posted
    January 10, 2004
    Terminated
    November 2, 2004
    Address
    Hwy 2 Km 58.0, Barceloneta, PR, 00617

    Description

    TDx/TDxFLx Tricyclic Antidepressants Reagent. Distributed under the following label: TDx/TDxFLx Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064.

    Reason

    Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.

    Action

    The Important Information Letter dated 11/17/03 was mailed to all ADx, TDx/TDxFL and AxSYM TCA reagent customers. The letters were sent to customers by Federal express Priority mail. The letter recommended contacting all customers who have received the reagents within the last 15 months.

    Distribution

    Distribution was nationwide.