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
The manufacturer's internal quality testing confirmed on 9 may 2011 indicated there may be a performance issue which may result in fam labeled products failing to amplify. the result of this failure to amplify is that mutant alleles are not called resulting in potential false negatives. during investigation of the performance issue it was determined that this product had not been licensed for use in canada.