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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A discrepancy was observed whereby the reagent on-board stability on the parameter setting sheets stated 90 days and the ifu states 60 days. while in-house studies have shown that the product is stable on-board for 90 days the 60 day stability claim will remain so that the parameter setting sheets ifu and regulatory documentation are aligned.