Z-0398-2017Class II

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

Name: Z-0398-2017 Siemens ADVIA Centaur Vitamin D Total Assay SMN SMN 10699533 (500 test)
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2016-10-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-10-05 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of Siemens ADVIA Centaur Vitamin D Total Assay SMN SMN 10699533 (500 test) on 2016-10-05. FDA classified it as Class II and gives the reason as "Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0398-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-05
Posted: 2016-11-11
Terminated: 2019-08-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens ADVIA Centaur Vitamin D Total Assay SMN SMN 10699533 (500 test)
Product code: MRG System, Test, Vitamin D
Reason for recall: Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples
Root cause tag: design
FDA root 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
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0398-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0397-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-11
Z-0398-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-11

Product code MRG

K110586Class IIAdvia Centaur Vitamin D Total AssaySiemens Healthcare Diagnostics, Inc. / cleared 2011-10-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)