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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Ortho clinical diagnostics recently received notification from novartis diagnostics regarding the potential for an increase in false positive assay results when using the chiron riba hcv 3.0 sia (strip immunoblot assay). internal testing of known positive specimens on retain lots yielded accurate results. therefore there is no evidence that true positive results are impacted.