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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Sekisui diagnostics has issued a field correction for the acetaminophen assay catalog number 2k99-20 505-10 and 505-30 because the interference for n-acetylcysteine (nac) has increased (resulting in a larger negative bias in acetaminophen concentration) relative to the level reported in the reagent package insert.