BEUDAMED
    FDA Recall Terminated

    Dimension Vista Ferritin (FERR) Flex reagent cartridge

    Recall: Z-2609-2017 · Initiated March 21, 2017

    Recall

    Recall Number
    Z-2609-2017
    Event Number
    76915
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    DBF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 21, 2017
    Posted
    May 5, 2017
    Terminated
    August 3, 2018
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    Description

    Dimension Vista Ferritin (FERR) 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.

    Action

    Siemens mailed an Urgent Medical Device Correction Letter to affected customers on 03/29/2017 to inform them of the issue. The notice explained the reason for the field action, Risk to Health and actions to be taken by the customer.

    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

    29,266 units