BEUDAMED
    FDA Recall Terminated

    CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer

    Recall: Z-0527-06 · Initiated December 16, 2005

    Recall

    Recall Number
    Z-0527-06
    Event Number
    34395
    Firm
    Abbott Laboratories
    FEI Number
    2919069
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 16, 2005
    Posted
    February 16, 2006
    Terminated
    April 13, 2006
    Address
    5440 Patrick Henry Dr, Santa Clara, CA, 95054-1113

    Description

    CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer

    Reason

    T-Cell test results and the respective absolute counts for the CELL-DYN Sapphire instrument using CD3/4/8 reagents can be overestimated by as much as 13%.

    Action

    The firm has sent notification letters dated Dec. 16, 2005 to all consignees requesting discontinuing of use, destruction of CD3/4/8 reagent if the lab does not plan to run on a CELL-DYN 4000 system.

    Distribution

    Nationwide and Canada, Venezuela, Germany, Hong Kong, Japan, Mexico and Singapore.

    Quantity

    871 units