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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Analytical studies showed that the nuclisens easyq enterovirus kit can not detect enterovirus serotype 68 and rhinovirus serotype 87. therefore biomerieux revised the instruction for use of nuclisens easyq enterovirus products in order to remove these serotypes from the list of the serotypes detected by the kit.