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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During an internal study some patient samples with total t4 concentrations above the measuring range of the access total t4 assay when diluted according to the access total t4 product instructions for use using one volume of sample with an equal volume of access total t4 calibrator s0 (zero) were falsely elevated up to 22%.