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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Kits may exhibit false agglutination with non-staphylococcus aureus colonies as well as the negative control reagent. quality control should be performed each day the kit is used. the kit should not be used if the reactions with the control organisms are incorrect.