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 intensity of the rotavirus test line signals generated by the incriminated rota positive control could be judged too weak. as a consequence one may erroneously conclude that the tested diagnostic kit quality is beyond the expectations and that weak positive signals could be missed with clinical samples.