Siemens ADVIA Centaur Vitamin D Total Assay 의 리콜

Recall

75394

Class 2

Z-0397-2017

2016-10-05

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150188

Vitamin d total- change in correlation between serum and plasma specimen tubes- negative bias with plasma vs. serum samples.

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.