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Recall Observatory FDA recall evidence

Device product

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

Z-0398-2017

October 05, 2016

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 75394
Status
Terminated
Classification
Class II
Quantity
37437 kits
Official record key
device-enforcement:Z-0398-2017

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

    reason.no_named_rule · v1.0.0

    Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples