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 is conducting a correction for the immulite 2000/immulite 2000 xpi immunoassay systems water and liquid waste bottles received starting may 2013. siemens has identified that the water and liquid waste bottle assemblies were manufactured with a quality issue. the smaller diameter opening of both bottles is undersized and/or deformed preventing the cap from closing or fastening securely to the bottle.