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 latex reagent component of the test kit fails to cause agglutination in patient samples containing levels greater than 250 ng/ml of d-dimer. the failure will give a false negative result for the test.