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 biotin concentration in the non-interfering table for dimension ft4l and tshl and dimension vista tsh is incorrect and the biotin concentration is being revised. in addition dimension vista ctni and mmb and dimension siro do not indicate biotin interference in the non-interfering table of the ifu. the ifu will be updated with the established claim for biotin.