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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Potentiel reconnection problem between the cobas 8000 core unit and the e602 immunoassay analyzer. this reconnection failure may occur following a power failure to the core unit pc and in rare circumstances could lead to incorrect patient results.