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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The software program that controls the heating and cooling of various subsystems such as the substrate heater and the reagent storage coolers may not start properly during system initialization. if this happens no event log message is generated and no test results are flagged.