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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Rhd master lot has incorrect deletion detection values. lot-specific deletion detection values released into basis global software for rhd master lot 16-284 may result in an incorrect phenotypical variant call due to the genotype being erroneously detected as having an exon 5 deletion.