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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It was determined that discrepant results in patient samples internal quality controls (icq) and external quality assessment (eaq) samples may be obtained for ceruloplasmin assay of specific lots used on roche cobas c analyzers.