BEUDAMED
    FDA Recall Terminated

    CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by Abbott Hematology, Santa Clara, CA

    Recall: Z-1629-2010 · Initiated June 8, 2009

    Recall

    Recall Number
    Z-1629-2010
    Event Number
    53212
    Firm
    Abbott Laboratories
    FEI Number
    2919069
    Product Code
    gkz
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 8, 2009
    Posted
    May 20, 2010
    Terminated
    December 3, 2010
    Address
    5440 Patrick Henry Dr, Santa Clara, CA, 95054-1113

    Description

    CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by Abbott Hematology, Santa Clara, CA

    Reason

    Use of Syringe LN 04H36-01 with the Die-cast syringe drive may result in leakage, leading to delay in reporting patient results.

    Action

    A Product Correction Letter and Customer Rely Form were sent to all currently active Cell -Dyn Sapphire customer. New customers are being notified with a Product Information Letter. For questions regarding this information, U,S, customers should call Customer Support at 1-877-4ABBOTT. Customers outside the U.S., please contact your local hematology customer support representative.

    Distribution

    Worldwide distribution: United States, Canada, Mexico, Anguilla, Australia, Argentina, Belize, Bermuda, Brazil, China, Chile, Columbia, Costa Rica, Ecuador, El Salvador, Germany, Guatemala, Haiti, Honduras, Hong Kong, Japan, Paraguay, Peru, Puerto Rico, Singapore, South Korea, Uruguay, and Venezuela.

    Quantity

    11 units