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 potential for negative biases when testing patient samples. an observed negative bias in patient samples could mask moderate increases in ca 125 which could potentially delay the use of additional diagnostic and therapeutic measures used to verify and treat disease relapses or progression. qc samples do not exhibit the bais observed with patient samples.