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 confirms lower than expected specificity rates that may increase the frequency of false positive test results for this assay. siemens believes that false positive results will lead to further investigation and that the possibility of misinterpretation and incorrect patient management are low.