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
Siemens has received customer complaints one positive control bias observed on immulite/immulite 1000 cortisol lkco 381 382 and 383. internal investigation confirmed a positive patient bias and control bias observed on the immulite/immulite 1000 cortisol lkco kit lots 381 382 and 383.