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
There is an error in the package insert pertaining to the co-oximeter parameters of the rapidqc complete controls. rapidpoint 405 system values and barcodes were transposed with those of the rapidlab 800 series system. rapidlab 1200 system values for neonatal bilirubin are incorrect.