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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Radiometer has identified that one lot of membrane boxes has been produced using an incorrect electrolyte solution. the incorrect solution causes the sensitivity of the pco2 electrode to be very low for which reason the calibration fails and results cannot be reported.