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 lot 0d0039 gives an abnormal rate of blue colonies that were not further confirmed as gbs (group b streptococcus). on this particular lot some enterococci could produce blue colonies instead of the pink to violet colonies that are expected for these organisms.