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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There is the possibility of under-recovery of dimension vista cyclosporine (csa) and cyclosporine extended range assay (csae) when patient's samples are processed from the small sample container (ssc). this field safety notice is for the non-expired lots of the dimension vista csa/csae assays.