BEUDAMED
    FDA Recall Terminated

    Clinical Chemistry Phosphorus assay

    Recall: Z-2398-2010 · Initiated May 4, 2010

    Recall

    Recall Number
    Z-2398-2010
    Event Number
    55700
    Firm
    Abbott Laboratories Inc.
    FEI Number
    2018433
    Product Code
    CEO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 4, 2010
    Posted
    September 10, 2010
    Terminated
    April 5, 2012
    Address
    820 Mission St, South Pasadena, CA, 91030-3142

    Description

    Clinical Chemistry Phosphorus assay

    Reason

    Product may give inaccurate results and aspiration errors with reagent configuration, including results outside of linear range & calibration failure.

    Action

    Abbott Laboratories issued a "Product Recall: Immediate Action Required" letter dated May 4, 2010 to consignees. The letter described the product, problem and action to be taken by the customer. The letter instructed the customer to: 1) Identify affected product in inventory 2) Discontinue use and destroy any remaining inventory of the affected lot: 7D71-21 3) Complete and return an enclosed Customer Reply Form 4) Order alternative kit sizes for Clinical Chemistry Phosphorus: LN 7D71-31 or 7D71-22 5) For AEROSET Systems, manually update parameters as described in the letter. 6) For ARCHITECT cSystems, implement alternative kit sizes without system changes. 7) Provide a copy of the letter to other laboratories that have been distributed the affected product. US customers can contact Abbott Customer Service at 1-877-4ABBOTT. Customers outside the U>S> are instructed to contact their local area Customer Service.

    Distribution

    Worldwide Distribution: US, including Puerto Rico, and countries of Germany, New Zealand, Trinidad/Tobago, Cayman Island, Hong Kong, Chile, Curacao, Jamaica, Australia, and Bahamas.

    Quantity

    3136