BEUDAMED
    FDA Recall Terminated

    Dimension Flex Reagent Cartridge C-Reactive Protein Extended Range (RCRP). In vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Measurement of C-Reactive Protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

    Recall: Z-1930-2009 · Initiated April 15, 2008

    Recall

    Recall Number
    Z-1930-2009
    Event Number
    52000
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    DCN
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    April 15, 2008
    Posted
    September 8, 2009
    Terminated
    September 9, 2009
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Dimension Flex Reagent Cartridge C-Reactive Protein Extended Range (RCRP). In vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Measurement of C-Reactive Protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

    Reason

    falsely elevated results in EDTA plasma samples

    Action

    Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice on April 15, 2008 informing their customers that the EDTA plasma specimen claim had been rescinded. Current lots in the firm's inventory have been put on hold and reworked with an Alert Card rescinding the EDTA plasma claim. Subsequent lots use a revised instruction for use stating "Do not use EDTA plasma" in the Specimen Collection and Handling Section. For further questions, contact Siemens Healthcare Diagnostics at 1-302-631-6564.

    Distribution

    Worldwide Distribution -- US, Austria, Bosnia, Czech Republic, Hungary, Slovakia, Serbia, Denmark, Estonia, Latvia, Lithuania, Norway, Sweden, Belgium, Cyprus, Canary Islands, France, Great Britain, Germany, Ireland, Italy, Netherlands, Poland, Russia, Portugal, Saudi Arabia, Spain, South Africa, Switzerland, Turkey, Yemen, Bahamas, Brazil, Canada, Mexico, Australia, Bangladesh, China, Hong Kong, Japan, Malaysia, Pakistan, and Taiwan.

    Quantity

    25,760 cartons