BEUDAMED
    FDA Recall Terminated

    ACCESS Estradiol Reagent Test System

    Recall: Z-0872-03 · Initiated May 8, 2003

    Recall

    Recall Number
    Z-0872-03
    Event Number
    26292
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    CHP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 8, 2003
    Posted
    May 29, 2003
    Terminated
    October 14, 2003
    Address
    200 South Kraemer Blvd W, 337, Brea, CA, 92822

    Description

    ACCESS Estradiol Reagent Test System

    Reason

    Short volume, resulting possibility of falsely elevated results.

    Action

    Consignees were notified by letter dated may 8, 2003. It requests destruction of inventory for credit.

    Distribution

    Nationwide and Canada

    Quantity

    1593 kits