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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Trinity biotech initiates a corrective field action for trinical reference plasma product code t5102 (lots r332037 r332037r and s287001). the protein c chromogenic value is misassigned in the these lots and can result in an erroneous protein c chromogenic activity result.