BEUDAMED
    FDA Recall Terminated

    AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, Diagnostics Division, Abbott Park, IL 60064

    Recall: Z-1462-2008 · Initiated January 21, 2008

    Recall

    Recall Number
    Z-1462-2008
    Event Number
    46740
    Firm
    Abbott Laboratories
    FEI Number
    1415939
    Product Code
    DKZ
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    January 21, 2008
    Posted
    May 14, 2008
    Terminated
    December 1, 2009
    Address
    100 Abbott Park Rd, Abbott Park, IL, 60064-3502

    Description

    AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, Diagnostics Division, Abbott Park, IL 60064

    Reason

    Error Message: If the Positive and Negative Interpretation Cutoff parameters (116/117) are edited after installation of the revised assay file, VRTX error #0002 in Task 40 is generated and the instrument locks up when it attempts to report an AxSYM Amphetamine/Methamphetamine II patient result.

    Action

    Consignees were sent a Product Correction-Immediate Action Required letter on 1/21/08. The letter provided users with the steps to take to temporarily correct the problem until the recalling firm is able to send a corrected assay file. Users were requested to return a customer reply letter acknowledging receipt of the letter. For additional information, contact 1-877-4ABBOTT.

    Distribution

    Worldwide Distribution including USA territory of Puerto Rico, and countries of Australia, Canada, Chile, Colombia, Germany, Mexico, New Zealand, South Korea, Taiwan, Thailand and Venezuela.

    Quantity

    1,270 disks