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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Quality issue on ca++ menbrane unit 942-046 and 942-060. wrinles might arise on the outer membrane upon installation. retention of fluids between the wrinkles can cause a positive bias of up to 15% when measuring on whole blood at a level of approx. 080 mmol/l.