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 manufacturer revised the endogenous claims for the acetaminophen assay on all systems. the limitation-interference section of the acetaminophen package insert have been updated to indicate the impact of icteric haemolytic or lipemic samples with low levels of acetaminophen.