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 have been reports of "abnormal reaction" errors occurring on calibrations qc and patient samples. the abnormal reaction flag is being triggered by an internal check in the method for atypical particle reagent aggregation. results reported with the abnormal reaction flag are accurate however as per the ifu results should not be reported and should be repeated.