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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Therakos recently became aware that some customers have experienced a higher rate of blood leaks than what is typical for this product. these leaks which occur between the centrifuge bowl and the drive tube may or may not be preceded by a system pressure alarm or a blood leak alarm and have been observed at various stages of treatment.