BEUDAMED
    FDA Recall Terminated

    Abbott CELL-DYN 3500 Hematology Analyzer

    Recall: Z-1199-2007 · Initiated May 11, 2007

    Recall

    Recall Number
    Z-1199-2007
    Event Number
    38322
    Firm
    Abbott Laboratories
    FEI Number
    2919069
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 11, 2007
    Posted
    August 29, 2007
    Terminated
    June 19, 2008
    Address
    5440 Patrick Henry Dr, Santa Clara, CA, 95054-1113

    Description

    Abbott CELL-DYN 3500 Hematology Analyzer

    Reason

    The product failed electrostatic discharge testing, which could result in product failure.

    Action

    Mandatory Technical Service Bulletins (TSB) are being issued to Field Service to upgrade all instruments in the field. All customers will be contacted by Field Service to schedule this mandatory upgrade. The upgrades are expected to take 12 months.

    Distribution

    Worldwide, including USA, Puerto Rico, Canada, Mexico, Argentina, Australia, Bahamas, Brazil, Chile, China, Colombia, Costa Rica, Dominican Republic, El Salvador, Ecuador, Germany, Guatemala, Hong Kong, Jamaica, Japan, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan, Thailand, Uruguay, and Venezuela.

    Quantity

    3,429 units, all models