BEUDAMED
    FDA Recall Terminated

    CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01,Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA

    Recall: Z-0706-2007 · Initiated September 29, 2004

    Recall

    Recall Number
    Z-0706-2007
    Event Number
    37453
    Firm
    Abbott Laboratories
    FEI Number
    2919069
    Product Code
    GIF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 29, 2004
    Posted
    April 3, 2007
    Terminated
    May 1, 2007
    Address
    5440 Patrick Henry Dr, Santa Clara, CA, 95054-1113

    Description

    CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01,Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA

    Reason

    Elevated platelet background count results-some products may show a higher than expected platelet background count when used on the CELL-DYN 3200 System and report patient results that are unacceptable-out-of-range

    Action

    On September 29, 2004, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be disposed.

    Distribution

    Class II Recall-Worldwide Distribution- USA including states of IL, TX, GA, and PA. and countries of Argentina, Australia, Bahamas, Barbados, Brazil, British Virgin Islands, Colombia, Dominican Republic, Germany, Hong Kong, Japan, Korea, New Zealand, Puerto Rico, Singapore, Taiwan, Thailand, Trinidad & Tobago, Uruguay, and Venezuela.

    Quantity

    27,411 units