BEUDAMED
    FDA Recall Terminated

    IMMULITE 2000/IMMULITE 2000 XPi Anti HBc

    Recall: Z-1675-2018 · Initiated January 2, 2018

    Recall

    Recall Number
    Z-1675-2018
    Event Number
    79505
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    LOM
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    January 2, 2018
    Posted
    May 4, 2018
    Terminated
    February 10, 2023
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    IMMULITE 2000/IMMULITE 2000 XPi Anti HBc

    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.

    Action

    Siemens Healthcare Diagnostics issued a recall in March 2017 for products with incorrect units for biotin in the Instructions for Use. After further investigation, recalling firm determined that more Siemens products also had missing or incorrect information in the IFUs for which two recalls were initiated, and Amended Corrections and Removals Reports were submitted to the FDA

    Distribution

    Nationwide and Canada, Mexico, and Thailand