BEUDAMED
    FDA Recall Terminated

    ICON 25 hCG Test Kit

    Recall: Z-0163-04 · Initiated October 31, 2003

    Recall

    Recall Number
    Z-0163-04
    Event Number
    27678
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    JHI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 31, 2003
    Posted
    July 20, 2004
    Terminated
    May 17, 2004
    Address
    200 S Kraemer Blvd, Brea, CA, 92821-6208

    Description

    ICON 25 hCG Test Kit

    Reason

    False negative urine results are being observed at an increasing rate.

    Action

    Firm sent letter to customers on 31 OCT 03 expressing not to use kits and that another lot will be substituted. Destruction of recalled lot is requested.

    Distribution

    Nationwide and Canada (limited).

    Quantity

    9040 kits