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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In response to customer feedback siemens evaluated alternate statistical methods to determine if an alternate method would be a better fit for the reference range data published in the ifu. our investigation concluded that the lms method provided a better fit to the data and produced ranges more consistent with the expected physiological change in igf-i levels compared to use of the weighted average results reported in the ifu.