BEUDAMED
    FDA Recall Terminated

    Coulter LH500 Hematology Analyzer: Part Numbers 178832, 178833, 178834

    Recall: Z-1245-06 · Initiated April 17, 2006

    Recall

    Recall Number
    Z-1245-06
    Event Number
    35602
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    LOQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 17, 2006
    Posted
    July 18, 2006
    Terminated
    April 19, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Coulter LH500 Hematology Analyzer: Part Numbers 178832, 178833, 178834

    Reason

    Beckman has confirmed that erroneous results could be reported when the workstation database crashes.

    Action

    A Product Corrective Action (PCA) letter was sent week of April 17, 2006 via US mail. The letter outlines action to be taken to avoid potential erroneous results. Firm targeting 75% effectivenss checks.

    Distribution

    Nationwide and Canada

    Quantity

    759