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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Customer complaints identified two software vulnerabilities when using xn-series software version 00-16 through version 00-19. one software issue impacts all xn-series analyzer configurations the other occurs only with the xn-9000 configuration that consists of multiple xn-series analyzers on an automation line. a device correction is required for the xn-series hematology analyzers. this correction provides countermeasures to prevent incorrect demographic information and incorrect data transmission to the laboratory information system (lis). the correction was initiated on monday february 7 2017 in canada.