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 confirms that three issues were identified where the system may pass calibration and qc when it should not. these include auto-calibration with flagged system related errors auto-calibration with a lot change and reagent pack switching mid-calibration or mid-qc. users are being advised when any of the three situations occur to perform the calibration or qc again.