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
Ocd internal testing has confirmed the potential for positively biased results generated when using vitros ca 19-9 reagent pack and calibrator lot 1320. the average bias observed is 30% for results with concentration 37 u/ml.