BEUDAMED
    FDA Recall Terminated

    Abbott AxSYM System Digoxin III Reagent Pack

    Recall: Z-1202-2007 · Initiated March 30, 2007

    Recall

    Recall Number
    Z-1202-2007
    Event Number
    37904
    Firm
    Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila
    FEI Number
    2623532
    Product Code
    KXT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 30, 2007
    Posted
    August 29, 2007
    Terminated
    June 10, 2011
    Address
    Barceloneta, PR, 00617-3009

    Description

    Abbott AxSYM System Digoxin III Reagent Pack

    Reason

    Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM Digoxin III assay.

    Action

    On Abbott letterhead dated March 30, 2007 - The instructions are to provide a copy of the accompanying Product Correction Letter to the laboratory manager/supervisor responsible for AxSYM Digoxin II or AxSYM Digoxin III testing. The laboratory manager/supervisor should complete the information on the letter acknowledging receipt of the product Correction Letter and Fax the Customer Reply Form, prior April 12, 2007 to Fax number 1-800-777-0051.

    Distribution

    Worldwide, including USA, Puerto Rico, Canada, Uruguay, Germany, Japan, Hong Kong, South Korea, Australia, and New Zealand.

    Quantity

    2,579 kits