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 received customer complaints regarding qc isolates when tested on the walkaway instrument. following the installation of labpro 3.01 panel update -01 and utilization of the panel type pos combo 33 (pc33) an issue has been confirmed for qc isolates when tested on the walkaway instrument. this issue only applies to those that have installed the lp v3.01 panel update-01 (9800-3768 compact disk). qc issue affects combo type panels.