Class 2 Device Recall Siemens ADVIA Centaur Vitamin D Total Assay

• Date Initiated by Firm: October 05, 2016
• Create Date: November 11, 2016
• Recall Status: Terminated on August 29, 2019
• Recall Number: Z-0398-2017
• Recall Event ID: 75394
• 510(K)Number: K110586
• Product Classification: System, test, vitamin d - Product Code MRG
• Product: Siemens ADVIA Centaur¿ Vitamin D Total Assay; SMN SMN 10699533 (500 test)
• Code Information: All lot codes
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc; 333 Coney St; East Walpole MA 02032-1516
• For Additional Information Contact: SAME; 508-668-5000
• Manufacturer Reason for Recall: Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples
• FDA Determined Cause: Device Design
• 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.
• Quantity in Commerce: 37437 kits
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MRG and Original Applicant = Siemens Healthcare Diagnostics Inc.