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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Siemens healthcare diagnostics has observed a system-to-system bias between the tni-ultrat assay on the advia centaur cp and advia centaur/advia centaur xp/advia centaur xpt systems with the advia centaur cp generating lower results than the advia centaur/advia centaur xp/advia centaur xpt system. this observation impacts customers who use the tni-ultra assay on both the advia centaur cp and advia centaur/advia centaur xp/advia centaur xpt systems interchangeably when interpreting serial testing in patient samples. this communication does not impact customers who use tni-ultra results solely from either the advia centaur/advia centaur xp/advia centaur xpt system or the advia centaur cp system.