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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The kit contains an error in the instructions for use section 13.2 reference standard. in the table titled males the row for boys aged 9yrs the 2.5 percentile should be 63 not 36ng/ml and the row for men aged 46-50yrs the 25 percentile should be 129 not 126ng/ml.