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 has received and confirmed complaints of elevated cortisol calibration slopes that are outside of the defined reagent lot specific calibration slopes when using cortisol reagents prior to the end of the reagent shelf life. when this occurs the system will flag the failed calibration of the assay and quality control and patient results can not be generated.