BEUDAMED
    FDA Recall Terminated

    TDx/TDxFLx Methadone, list 9676-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    Recall: Z-0510-04 · Initiated December 5, 2003

    Recall

    Recall Number
    Z-0510-04
    Event Number
    27971
    Firm
    Abbott Laboratories HPD/ADD/GPRD
    FEI Number
    1415939
    Product Code
    DJR--
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 5, 2003
    Posted
    February 4, 2004
    Terminated
    April 25, 2005
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    TDx/TDxFLx Methadone, list 9676-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    Reason

    The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table

    Action

    Field Correction recall by Important Product Information letter dated 12/5/03, sent via Federal Express Priority on the same date to all customers receiving the affected reagents. The accounts were informed of the incorrect values for the Specific Performance Characteristics listed in the package inserts of the reagent kits. The letters contained a table listing the incorrect values and the correct values for each of the products, and the users were instructed to replace their product inserts with the enclosed revised package inserts for all product specific reagent kits in their laboratory.

    Distribution

    Nationwide and internationally through Abbott subsidiaries in Mexico, Guatemala, Colombia, Chile, Argentina, Brazil, Puerto Rico, San Salvador, Canada, England, Japan, Singapore, Hong Kong, Taiwan, Thailand, Korea, Australia, New Zealand, Honduras, Costa Rica, Bahamas, Panama, Dominican Republic and China.

    Quantity

    528 kits