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
When the au480 clinical chemistry analyzer operates using the real-time online function and the number of barcode digits in the sample id barcode label does not match the instrument configuration setting in the "requisition format" menu and in the lis system the au480 clinical chemistry analyzer generates alarm 6042 "online mismatch" and the sample is not processed. if the number of barcode digits configured in the lis middle wareand au480 settings match the customer will not experience the issue. the issue does not generate incorrect results but may cause a delay in processing the sample.