BEUDAMED
    FDA Recall Terminated

    Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic.

    Recall: Z-1017-2010 · Initiated June 16, 2009

    Recall

    Recall Number
    Z-1017-2010
    Event Number
    52958
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 16, 2009
    Posted
    March 8, 2010
    Terminated
    November 30, 2010
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic.

    Reason

    Incorrect result: patient sample BUN results reported may be higher or lower than actual level.

    Action

    Siemens issued an Urgent Field Safety Notice dated 6/16/09 to all affected customers instructing them to discontinue use of the Dimension Vista BUN Flex reagent cartridge lot 09061AA.

    Distribution

    Worldwide distribution: USA, Australia, Canada, Germany, Japan, and Korea.

    Quantity

    1254 cartons