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 acceptable performance range published in the directcheck microcoagulation quality control (product code dcjpt-a lot number g9dpa005 only) package insert is inaccurate. the posted range printed on the package insert reads "3.7 - 6.5 inr". the correct range is 4.1 - 8.7 inr.