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 liaison h. pylori sa kit reports an incorrect volume for the sample diluent component.Kit content states 40ml and specimen diluent component contains 45mls. the component label and instructions for use are correct at 45ml.