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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There is a potential where the elecsys vitamin d3 kit lot specific reagent is aging and would require shortened kit calibration intervals.In consequence the calibration frequency need to be changed from 7 to a 4 days interval for the identified reagent lots.