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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Flow class i positive control serum products were not tested for hbsag hcv hiv1/2 as required for human source components for use as in vitro diagnostic product. process and requirement in place for testing however processes were not followed.