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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Single factor applications at the cs-2000i systems might show increased values if a low sample at the lower end of the measuring range is followed by a high sample at the upper measuring range. the extent of carry over and the clinical impact are different depending on the factor assay.