FDA-Device2016-11-23Class II
Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test)
Siemens Healthcare Diagnostics, Inc
Hazard
Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples
Sold states
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
Affected count
69781 kits
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0397-2017Don't want to check this manually?
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