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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An external study showed that performing tests with inactivated sera provides discrepend results. the index results obtained testing inactivated serum are lower compared to values obtained with fresh serum. this could lead for borderline sample to a drift in the overall result interpretation (i.E. from positive to equivocal from equivocal to negative from positive to negative).