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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The specimen and prepared sample stability claims stated in the product labeling for specimens prepared with cyto-stattetrachrome reagents (cd45-fitc/cd4-rd1/cd8-ecd/cd3-pc5 and cd45-fitc/cd56-rd1/cd19-ecd/cd3-pc5) when analyzed using a navios flow cytometer need to be revised. specimens or samples processed outside the updated stability claims may produce erroneous percent positive and absolute count results.