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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Contamintaion of the mirror from the optical system can lead to false positive signals in the early phase of measurement which can lead to the following failure pattern on a cobas h 232: "tnt elevated" displayed during the measurement but the final results is trop t (less than) 50ng/l iqc level-ii fails e-402 during a measurement.