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 healthcare diagnostics has received customer complaints regarding crotor an accessory part lot nh42-251-09 for the stratus cs stat fluorometric analyzer. there is a low frequency defect in the gel filling of this lot that may result in inadequate separation of cells during centrifugation.