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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Randox has identified a labelling error for 2 of the test methods listed for quantification of total protein (urine). the values for the mean of all instruments are incorrect by a factor of 10. this does not affect the performance or stability claims of the product. instrument specific values are correct.