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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The device may fail to conform to a claim made by the manufacturer or importer relating to its performance characteristics: oxidizing of the media (blue rings greater than 3 mm) is being reported before the end of shelf life in the port-a-cul tubes.