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 has confirmed an increase in the mean values of the controls when using immulite 2000 and immulite 2000 xpi troponin i kit lots 260 and above. patient samples are not affected however if qc fails there can be a delay in patient treatment.