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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Complaint received of biased glucose result on a vitros 5600 integrated system. investigation has found that under a very specific set of circumstances when the display/report is configured by the operator an erroneous result could be generated by the vitros 5600 integrated system.