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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When the reagent is used to monitor the effectiveness of unfractionated heparin therapy or oral anticoagulants there may be an erroneous drift of results with a higher than the clincally acceptable limits of heparin samples. the increased heparin sensitivity may lead to longer activated partial thromboplastin times (aptt) leading to inappropriately decreasing anticoagulant dosage. inappropriate reduction of anticoagulation increase the risk of thromboembolism.