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 manufacturer itc has determined that some citrate activated partial thromboplastin time (aptt) cuvettes may recover higher than expected results in normal individuals. investigation into the affected lot identified that when performing tests on non-heparinized e.G. normal blood samples results may average higher than historic values. test results performed on patients receiving heparin therapy are not affected.