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.
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The di-60 automated digital cell morphology analyzer shuts down the database and stops processing slides after 100 consecutive slides are run on one day. the following error message displays "no connection with the database." this is a software defect and impacts only the di-60 and di-60 with system di- 60 remote review software.