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 increasing number of complaints regarding the dako envision detection system have been noted. several customers using four antibodies against the biomarkers epstein-barr virus mum-1 smooth muscle actin and wilms tumor 1 protein have reported non-specific background staining that has in some instances interfered with interpretation of the staining results. to date only the four identified antibodies have exhibited the non-specific background staining.