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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It has been discovered that the feature "exit conditioning" may cause a risk to patients. when a new sensor cassette is installed the analyzer will automatically run extra calibrations and internal qc's for the first 24 hours. it is possible during sensor cassette start-up to press "exit conditioning". this will cancel the second start-up calibration and the 3 start-up qc's. it will not affect the remaining frequent calibrations. the analyzer does not indicate the exit from the conditioning and the patient results are not flagged for qc not being run.