Device product
Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test)
Z-0397-2017
Product summary
- Event
- Event 75394
- Status
- Terminated
- Classification
- Class II
- Quantity
- 69781 kits
- Official record key
device-enforcement:Z-0397-2017
Official wording
Reason: Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples
Code information: All lot codes
Distribution pattern: 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
Derived failure modes
-
Unknown
Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples