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.
데이터 추가 비고
원인
Incorrect standard human plasma (shp) predilution in the title line of the standard calibration curve table in the application sheets of all endogenous coagulation factors were detected in reference guide versions 3.00 3.01 3.02. the stated predilutions do not fit to the recommended dilution set of the last calibration curve point.