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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There has been a change to the acceptable range for the 'e' calibration coefficient guideline. the new guideline range is 5 to 8 (conventional units). the guideline range for lots prior to ga3099 is 6 to 9. the e coefficient range is a criterion used by customers to assess the validity of their calibration. siemens has also noted that some users are not updating scaler values when setting up a calibration (this was implemented beginning with lot ga3009) resulting in inaccurate values for both patients and controls.