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
Beckman coulter inc. identified the following issues with the above listed products: issue 1: after downloading interlaboratory quality assurance program (iqap) files to removable media the system prevents access to system setup screen and history logs. issue 2: the on-line help (ifu) instructions for lh 750 and lh 780 instruments do not provide the correct procedures to format a disk (cd) for saving or archiving data where those instruments are connected to small form factor (sff) computers.