BEUDAMED
    FDA Recall Terminated

    CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers.

    Recall: Z-0565-2007 · Initiated December 22, 2006

    Recall

    Recall Number
    Z-0565-2007
    Event Number
    37234
    Firm
    Abbott Laboratories
    FEI Number
    2919069
    Product Code
    GIF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 22, 2006
    Posted
    March 1, 2007
    Terminated
    November 28, 2007
    Address
    5440 Patrick Henry Dr, Santa Clara, CA, 95054-1113

    Description

    CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers.

    Reason

    Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire systems.

    Action

    Recall initated 12/22/2006. Product letters were sent to consignees, as well as a customer reply form. The letters were sent with customer reply forms. Responses will be tracked via the response forms included with letters.

    Distribution

    Nationwide, including California and Nevada. An Abbott Laboratories facility in Hong Kong.

    Quantity

    652 (20 L. each) cubitainers