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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Internal testing has confirmed low recovery of qc and patient samples. use of one of these lots may show a downward shift in qc and patient results. this decrease may cause a sample that is slightly above the 99th percentile (0.056 ng/ml) of a reference population to read below this value. at higher values of tni samples will remain positive and the bias is not clinically significant.