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 product has the potential to contain the incorrect edta additive volume. various amounts of edta additive in the tubes may lead to platelet clumping and clotting of the blood sample. platelet clumping causes false reduction of platelet counts the possible consequences of false reduction of platelet counts are erroneous results and specimen rejection. in the event that the clinician acts upon the erroneous results this could lead to unnecessary platelet transfusion hematologic work up including bone marrow biopsy steroid therapy splenectomy etc.