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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In this follow-up to a february 2016 field correction (ra-57392) siemens is expanding the warning of well-to-well accuracy shifts to additional lots (and all future lots until further notice) of dimension vista bun flex reagent cartridges resulting in inaccurate patient and/or quality/control results. not all flexes or wells are impacted. siemens is providing revised advice to customers to manage bun testing.