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 protective plastic sheet that is intended to cover and protect electronic components inside the xn-series analyzers was not positioned correctly during manufacturing. reagent from a leaking valve created a build-up of salt on an electronic component because of the misalignment of the protective sheet. the salt build-up created a salt bridge that allowed current to continue to flow create heat and eventually ignite adjacent resin parts inside the analyzer.