BEUDAMED
    FDA Recall Terminated

    Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma.

    Recall: Z-1869-2012 · Initiated May 8, 2012

    Recall

    Recall Number
    Z-1869-2012
    Event Number
    61889
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    CDD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 8, 2012
    Posted
    June 27, 2012
    Terminated
    April 3, 2014
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma.

    Reason

    Siemens Healthcare Diagnostics has confirmed that the presence of Intrinsic Factor Blocking Antibody in some patients can result in a false and significant elevation in the reported concentration of Vitamin B12 on the Dimension Vista System. This issue affects all lots of B12 Flex reagent cartridges on the Dimension Vista System.

    Action

    Siemens Healthcare Diagnostics Inc. sent a Urgent Device Recall letter to all affected customers dated May 2012. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed customers to immediately discontinue use of the device, quarantine and dispose of all inventory, ensure that your Medical Director reviews this letter as well as the attached physician letter. Please complete the attached Field Correction form and fax to 302-631-8467. Further questions please call 302-631-6311.

    Distribution

    Worldwide Distribution -- USA (nationwide) and the countries of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Great Britian, Italy, Netherlands, Norway, Portugal, Slovakia, South Africa, Spain, Switzerland, United Arab Emirates, Canada, New Zealand, and South Korea. *** Center Recommended Depth is Retail***

    Quantity

    59,735