BEUDAMED
    FDA Recall Terminated

    Package Insert for TDx/TDxFLx and TDxFLx Carbamazepine Reagents, REF 9515, item number 69-5121/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    Recall: Z-0277-04 · Initiated November 17, 2003

    Recall

    Recall Number
    Z-0277-04
    Event Number
    27780
    Firm
    Abbott Laboratories HPD/ADD/GPRD
    FEI Number
    1415939
    Product Code
    KLT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 17, 2003
    Posted
    July 20, 2004
    Terminated
    November 1, 2004
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    Package Insert for TDx/TDxFLx and TDxFLx Carbamazepine Reagents, REF 9515, item number 69-5121/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    Reason

    The package inserts contain incorrect values for the alternate unit (mol/L) Control Ranges

    Action

    Field Correction recall by undated letter sent on 11/17/03 to all customers receiving the affected lots of reagents. The accounts were informed of the incorrect values for the alternate unit (mol/L) Control Ranges 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 use the correct values listed in the table for the assays. The letters also listed the package insert item numbers for the updated inserts being used in current reagent production.

    Distribution

    Nationwide and internationally through Abbott subsidiaries in Mexico, Guatemala, Venezuela, Colombia, Peru, Chile, Uruguay, Argentina, Brazil, Puerto Rico, San Salvador, Canada, Germany, England, Japan, Singapore, Hong Kong, India, Taiwan, Thailand, Malaysia, Pakistan, Korea, Australia, New Zealand, Honduras, Costa Rica, Aruba, Bahamas, Panama, St. Croix, Jamaica and Paraguay.

    Quantity

    2,893 kits