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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Bioarray solutions ltd. has determined that rhd master lot 16-166 has incorrect error cutoff values. lot-specific error cutoff values for the rhd snp markers released into the basis global software for rhd master lot 16-166 can create indeterminate genotype calls ("xx") which may impact the accuracy of the variant allele calls.