BEUDAMED
    FDA Recall Terminated

    XSYSTEMS AxSYM Multiconstituent Controls for Abused Drug Assays, list 9687-12; Abbott laboratories, Abbott Park, IL 60064 USA

    Recall: Z-1539-05 · Initiated June 27, 2005

    Recall

    Recall Number
    Z-1539-05
    Event Number
    32540
    Firm
    Abbott Laboratories MPG
    FEI Number
    1415939
    Product Code
    DIF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 27, 2005
    Posted
    September 14, 2005
    Terminated
    January 18, 2006
    Address
    100 Abbott Park Rd, Abbott Park, IL, 60064-3502

    Description

    XSYSTEMS AxSYM Multiconstituent Controls for Abused Drug Assays, list 9687-12; Abbott laboratories, Abbott Park, IL 60064 USA

    Reason

    The XSYSTEMS Multiconstituent Controls accessory insert (commodity number 34-3067/R6) does not contain the correct control ranges for the AxSYM Opiates assay.

    Action

    On 6/27/05, Abbott sent the customer letter via FedEx to all XSYSTEMS Multiconstituent Controls customers that received List Number 9687-12 lots 17270M100 and/or 18177M300 and/or AxSYM Opiates reagents (List Number 3B25-20) since June 01, 2004. The letters explained that the multiconstituent control ranges for morphine were not updated in the MCC Accesory insert at the same time they were updated in the AxSYM Opiates reagent package insert in 2004. The accounts were requested to review their current control ranges for the AxSYM Opiates assay, and verify that they are using either the control ranges in the AxSYM Opiates reagent package insert or control ranges established by their facility. They were also instructed to follow their facility''s normal policies and procedures for communicating with health care providers served by their laboratory. The accounts were requested to complete and return the enclosed reply sheet acknowledging the receipt of the letter and the dissemination of the letter to the laboratory manager/supervisor responsible for the assays.

    Distribution

    Nationwide, including Puerto Rico, and internationally to Argentina, Australia, Barbados, Bermuda, Brazil, Canada, Cayman Island, Chile, China/Hong Kong, Columbia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Germany, Honduras, Jamaica, Korea, Mexico, New Zealand, Panama, Peru, Singapore, St. Vincent, Thailand, Trinidad and Taiwan

    Quantity

    4151 kits