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 version 3.0 of the cobas taqman mtb test definition file product 2 in table 1 cat 0557445519 has an incorrect target elbow cutoff of 48 instead of 50. this test definition file tdf is used with the cobas taqman mtb test product 1 in table 1 cat 04803531190 patient.