BEUDAMED
    FDA Recall Terminated

    Dimension CREA (Creatinine) and Dimension Vista CREA (Creatinine); The CREA method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatinine in human serum, plasma and urine.

    Recall: Z-2741-2015 · Initiated July 15, 2015

    Recall

    Recall Number
    Z-2741-2015
    Event Number
    71725
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JFY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 15, 2015
    Posted
    September 5, 2015
    Terminated
    March 24, 2017
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    Description

    Dimension CREA (Creatinine) and Dimension Vista CREA (Creatinine); The CREA method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatinine in human serum, plasma and urine.

    Reason

    Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for a creatinine concentration of 1.5 mg/dL when hemolysis exceeds 200 mg/dL and 300 mg/dL respectively.

    Action

    Siemens sent an Urgent Medical Device Correction letter, dated July 2015, was provided to all Dimension CREA and Dimension Vista CREA customers who received the products to notify them of the issue, the potential risk to health, and actions to be taken by customers. If you have any questions please contact your Siemens Customer Care Center Technical Solutions at (800) 441-9250, or your local Siemens Technical Support Representative.

    Distribution

    Worldwide Distribution - US (nationwide) and to the countries of : Afghanistan, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia Herzegovinia, Bulgaria, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Ghana, Great Britain, Greece, Guatemala, Hungary, Iraq, Ireland, Honduras, Hong Kong, Iceland, Indonesia, India, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Libya, Macedonia, Malaysia, Mali, Mexico, Myanmar, Morocco, Netherlands, Nepal, Nicaragua, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tunisia, Turkmenistan, United Arab Emirates, Uruguay, Venezuela, Vietnam and Yemen.

    Quantity

    Total number Dimension Vista - 32,165, Dimension - 238,634