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
This reagent is demonstrating a positive bias in patient results. patient results which are greater than the upper limit of normal (30.2 u/ml) are biased on average 40% higher than previous lots. patient results which are less than the upper limit of normal (below 30.2 u/ml) are biased on average 55% higher than previous lots.