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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Specified lot can result in clinical significant lower pai values compared to previous lots. high pai concentrations (>10 u/ml) might be underestimated and in the low reference range patient results might be found even below the reference range.