Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Siemens healthcare diagnostics has confirmed a change in bias between serum and plasma specimen tubes with the advia centaur vitamin d assay as compared to instructions for use (ifu). newly evaluated data demonstrate a deming regression slope between 0.93 and 0.95 for plasma samples as compared to serum samples whereas the specimen collection comparison data provided in the ifu indicates a linear regression slope of up to 1.09.