BEUDAMED
    FDA Recall Terminated

    Dimension Free Thyroxine (FT4L) Flex reagent cartridge

    Recall: Z-1669-2018 · Initiated January 2, 2018

    Recall

    Recall Number
    Z-1669-2018
    Event Number
    79505
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    CEC
    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

    Dimension Free Thyroxine (FT4L) Flex reagent cartridge

    Reason

    The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.

    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