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 internal investigation confirmed that the immulite/immulite 1000 and the immulite 2000/ 2000 xpi cea assay does not meet the (within-run precision specifications as per the immulite/immulite 1000 and the immulite 2000/2000 xpi ifu's for all in date immulite cea kit lots. the immulite/immulite 1000 and the immulite 2000/2000 xpi cea inter-assay (total precision) shows equivalence to the ifu and is therefore not impacted by this issue.