BEUDAMED
    FDA Recall Terminated

    Dimension IBCT Flex Reagent Cartridge. The total (IBCT) method used on the Dimension system is an in vitro diagnostic test intended to quantitatively measure Total Iron Binding capacity in human serum and plasma.

    Recall: Z-2385-2010 · Initiated December 16, 2009

    Recall

    Recall Number
    Z-2385-2010
    Event Number
    54460
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JMO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 16, 2009
    Posted
    September 8, 2010
    Terminated
    October 25, 2010
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Dimension IBCT Flex Reagent Cartridge. The total (IBCT) method used on the Dimension system is an in vitro diagnostic test intended to quantitatively measure Total Iron Binding capacity in human serum and plasma.

    Reason

    Test produces falsely elevated IBCT results and Abnormal Reaction test report messages on heparinized plasma samples.

    Action

    Siemens issued an "Urgent Field Safety Notice" letter dated December 2009 to users identifying the issue and affected product. Customers were instructed not to use heparinized plasma samples for IBCT testing. IBCT Instructions for Use (IFU) has been updated to reflect that heparinized plasma is no longer an acceptable sample type. Beginning with lot ED0341, the new IFU will be packaged in the carton with the IBCT Flex reagent cartridges. Consignees were requested to forward the notification letter to anyone to whom the product was distributed. The Siemens Technical Solutions Center can be contacted at 800-441-9250.

    Distribution

    Worldwide Distribution: USA (all states) and the countries of Canada, Switzerland, New Zealand, Australia, Japan, and South Korea.

    Quantity

    unknown - all lots involved