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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Bd stem cell control is unable to optimize (setup) bd facscanto instruments. in that case the customer would not be able to continue to run the bd stem cell enumeration assay. the enumeration of absolute cd34+ cell count results would not be possible on the instrument. these counts are used in the planning process for stem cell transplants.