BEUDAMED
    FDA Enforcement Class II Terminated

    IMMULITE ¿ /IMMULITE ¿ 1000 CEA

    Recall: Z-1678-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1678-2018
    Event ID
    79505
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 16, 2018
    Initiation Date
    January 2, 2018
    Classification Date
    May 4, 2018
    Termination Date
    February 10, 2023
    Address
    511 Benedict Ave, N/A, Tarrytown, NY, 10591-5005, United States

    Description

    IMMULITE ¿ /IMMULITE ¿ 1000 CEA

    Reason

    Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

    Code Info

    CEA, CEA (IMMULITE/IMMULITE 1000, LKCE1), (IMMULITE 2000/IMMULITE 2000 XPi, LKCE2, LKCE6) Lot codes: 0355 0356 0357

    Distribution

    Nationwide and Canada, Mexico, and Thailand

    Quantity

    N/A