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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Sysmex has identified a software bug with cs-2000i and cs-2100i software version 60 (v00-60) and all previous software versions. in the software certain error flags highlighted for review are automatically validated and sent to the host computer. these error flags are not being held back for manual review as expected.