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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Potential deficiency in providing the correct canadian package insert for specific lots of the hiv combi pt assay. the users were only provided the international version of the package insert. no false result could be generated since the difference between the two versions has no impact on test results or interpretation.