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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Lot number r0971 of po2 membrane boxes has been produced using an incorrect electrolyte solution. the po2 membrane inner solution contains glycerol which can be reduced at the cathode causing a suddenly rising zero current. this will happen after anything between hours and days causing the membrane unit to fail the following cal2 calibration.