Recall Z-0397-2017 ยท MRG System, Test, Vitamin D
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Vitamin D Total Assay SMN 10699201 (100 test)
| Date | Oct 5, 2016 |
| Status | Terminated |
| Reason | Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples |
| 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 F |
| Quantity | 69781 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110586 | ADVIA CENTAUR VITAMIN D TOTAL ASSAY Siemens Healthcare Diagnostics, Inc., Oct 14, 2011 |