BEUDAMED
    FDA Recall Terminated

    Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303

    Recall: Z-1015-05 · Initiated May 26, 2005

    Recall

    Recall Number
    Z-1015-05
    Event Number
    32268
    Firm
    Diagnostic Products Corp
    FEI Number
    3005250747
    Product Code
    DHX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 26, 2005
    Posted
    July 16, 2005
    Terminated
    February 3, 2006
    Address
    5210 Pacific Concourse Dr, Los Angeles, CA, 90045-6900

    Description

    Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303

    Reason

    Adverse trend in stability, controls biased or out of range.

    Action

    Recall was initiated by phone using a script, to be followed up with a letter and response form.

    Distribution

    Nationwide and to Syria, United Kingdom, Puerto Rico, Aruba, Kuwait.

    Quantity

    269