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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There is a low frequency of non-repeatable falsely elevated ctni results without an associated error message. these elevations may cause a sample that would be within the 99th percentile of the reference population 0.07 ng/ml to read above this value. if this occurs the ctni result would be expected to be discordant with the clinical picture including the classic rise and fall in concentration upon serial sampling.