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 tabulation error in the integrated data management system (idms) software product code 464100 versions 7.1 through 7.3 used with the hemochron response instrument that affects the operator and the device performance summary reports for two electronic quality control (eqc) tests.