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 identified multiple issues with advia centaur xpt system software versions v1.0.1 (bundle 1.0.912 smn 10819704) v1.0.2 (bundle 1.0.1086 smn 11219806) v1.0.3 (bundle 1.0.1108 smn 11220781) and v1.1 (bundle 1.1.243 smn 11221979). these issues may affect the results generated by the system and are described below: 1. sample tip error 2. daily maintenance 3. result reporting for high/low linearity samples 4. auto-repeat conditions 5. barcode misreads in rack id mode 6. low probe wash 7. las communication 8. system status unknown.