BEUDAMED
    FDA Recall Terminated

    COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R

    Recall: Z-0475-06 · Initiated December 15, 2005

    Recall

    Recall Number
    Z-0475-06
    Event Number
    34380
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    GKJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 15, 2005
    Posted
    February 4, 2006
    Terminated
    January 26, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R

    Reason

    There is a risk of sample misidentification when processing samples in the Manual aspiration mode.

    Action

    A Product Corrective Action letter will be mailed the week of Dec 19, 2005 to all COUL TER@ LH700 Series System & COUL TER@ GEN.STM System customers instructing them of a rare risk of sample misidentification. (Letter will be sent by US mail)

    Distribution

    Nationwide and Canada

    Quantity

    1134