BEUDAMED
    FDA Enforcement Class II Terminated

    Dimension Vista Estradiol (E2) Flex reagent cartridge

    Recall: Z-2608-2017 · Reported June 28, 2017

    Enforcement

    Recall Number
    Z-2608-2017
    Event ID
    76915
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 28, 2017
    Initiation Date
    March 21, 2017
    Classification Date
    June 16, 2017
    Termination Date
    August 3, 2018
    Address
    500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States

    Description

    Dimension Vista Estradiol (E2) Flex reagent cartridge

    Reason

    The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.

    Code Info

    Device Listing Number # D121541 Lot # 16148AA, 16190BA, 16201BA, 16228BC, 16256BA, 16277BB 16298AB, 16343BE,17005BC

    Distribution

    Product was distributed throughout the United States and Canada, United Arab Emirates, Argentina, Austria,Australia,Bangladesh,Belgium,Brazil,Canada Switzerland,China,Columbia,Czech Republic,Germany,Denmark,Algeria Egypt,Spain,Finland,France,Great Britain,Greece,Croatia,Indonesia,Ireland India,Italy,Japan,Canary Islands,Republic of Korea,Kuwait,Lebanon,Latvia Macedonia,Netherlands,Norway,New Zealand,Philippines,Poland,Portugal Qatar,Saudi Arabia,Slovenia,Slovakia,Turkey,Taiwan,South Africa

    Quantity

    1,697 units