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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Failure to conform to claim: clinical performance does not meet the supporting clinical study data for % recovery poor separation resulting in a reduced number of recovered mononuclear cells. having an insufficient number of isolated mononuclear cells may lead to possible specimen recollection potential delay of treatment and in remote cases it could lead to erroneous results. no adverse events have been reported for this issue.