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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A software issue was identified in system software 4.2 and 4.2.1 which may result in the incorrect handling of a wash arm dispense plate motion failure. instead of generating a red 'warning' event and stopping sample processing the system will post a yellow 'caution' event and continue to operate with the dispense plate in an elevated position until the instrument is reinitialized. potentially affected results are not flagged.