BEUDAMED
    FDA Recall Terminated

    Siemens ADVIA Centaur Vitamin D Total Assay SMN SMN 10699533 (500 test)

    Recall: Z-0398-2017 · Initiated October 5, 2016

    Recall

    Recall Number
    Z-0398-2017
    Event Number
    75394
    Firm
    Siemens Healthcare Diagnostics, Inc
    FEI Number
    1219913
    Product Code
    MRG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 5, 2016
    Terminated
    August 29, 2019
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    Description

    Siemens ADVIA Centaur Vitamin D Total Assay SMN SMN 10699533 (500 test)

    Reason

    Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples

    Action

    Siemens issued an Urgent Medical Device Correction (UMDC) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on October 5, 2016 to be delivered to customers on October 6th, 201 6. An Urgent Field Safety Notice ~UFSN) was sent out for distribution to all customers outside the United States on October 5, 2016. These notices inform the customer of the change in correlation between serum and plasma specimen tube results generated on the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT Vitamin D Total assay. A revised letter was issued on November 7, 2016 by Fedx for delivery on November 8, 2016 and advises users to: In the interim, Siemens requires that customers discontinue use of plasma tubes for specimen collection for the ADVIA Centaur Vitamin D Total assay until further notice. Customers can continue to use the ADVIA Centaur Vitamin D Total assay with serum specimen collection tubes. Accounts to Complete and return the Field Correction Effectiveness Check Form attached within 30 days. Review the letter with your Medical Director. and retain this letter with your laboratory records, and forward this letter to those who may have received this product. Question contact your Siemens Customer Care Center or your local Siemens technical support representative.

    Distribution

    Nationwide Foreign: Afghanistan, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Georgia, Germany, Great Britain, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Italy, Japan, Jordan, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Serbia, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, Uruguay, Vietnam

    Quantity

    37437 kits