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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Following internal investigation a note and a revised disclaimer for hemolysiswere added to the v.10 method sheet and the onboard stability of the calibrating reagent were from 24 to 5 hours in the v.7 method sheet.