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
During some internal testing at siemens it was discovered that the d50 (glucose sensor) and d51 (lactate sensor) error codes were not functioning on the rapidlab 1260 and rapidlab 1265 instruments. glucose and lactate sensors that are not completely seated with the contacts on the instrument should alert the operator with a d50 (glucose sensor) error or a d51 (lactate sensor) error.