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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The presence of human anti-bovine antibodies (habia) in a patient sample has been shown to cause an over-estimation of results with the hemosil von willebrand factor activity reagent. patient samples that contain large amounts of this habia interference can exhibit significant positive bias. the effects of this worst case situation can change a patient result from abnormal to normal with potentially severe impact to patient treatment.