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 is notifying customers to discontinue use of dimension vista alkaline phosphatase calibrator (alp cal) kc330 lot 2ad052. siemens has received customer inquiries regarding correlation slope bias when comparing the dimension vista alp method to the dimension alp method. an internal investigation has confirmed that the activity of the dimension vista alp calibrator kc330 changes as the product ages and contributes to this correlation slope bias as well as accuracy shift.