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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Analysis of patient samples received in complaint investigations showed that several samples caused unspecific signals up to 22 u/ml. the unspecific signals are neither caused by anti-sm antibodies nor by anti-streptavidin antibodies but are due to other unspecific signals with an as yet unknown cause.