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 have received customer complaints regarding the potential of dimension crea to increase qc recovery and imprecision over time from open well. qc results shift high over time within a flex well and then recover near the qc target or expected value in a newly opened fresh well. the change in qc recovery within a flex well can be as high as 0.2 mg/dl in a 24 hours period. this challenges the dimension crea flex open well stability claim of 5 days.