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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Data from long term stability monitoring shows that there is a decline in sensitivity performance of the simplired d-dimer kits containing test reagent 1012-34437. this decline in sensitivity performance may affect qualitative results. false negative results are possible on the simplired d-dimer test which may incorrectly influence the clinical diagnostic decision and could in some circumstances contribute to a delay in the diagnosis of deep vein thrombosis (dvt) or pulmonary embolism (pe).