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
Internal investigations revealed an interference with lipemia and rheumatoid factors in the increased rerun mode for tina-quant kappa gen.2 and tina-quant lambda gen.2. as a consequence the increased rerun function for both assays will be removed from the respective method sheets and the new values and new ratios will be changed in the next version of the method sheets.