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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This reagent is contained within legionella latex test kit dr0800m lot 1316151. an internal investigation has confirmed that there is potential for a weak or negative reaction when using this reagent lot with serogroup 9 isolates. this may result in a delay to the correct characterization of l. pneumophila serogroup 9 isolates.