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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Siemens healthcare diagnostics has confirmed an increase in complaints regarding elevated urine sodium quality control (qc) exceeding acceptable qc ranges with the dimension vista imt system. siemens observed a greater urine sodium drift with urine qc than urine patient samples. not all imt sensors exhibit the described urine sodium qc drift. current lots and all future lots are potentially affected until this issue is resolved.