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 manufacturer medion grifols diagnostics ag has become aware through their routine vigilance process that the antigen table provided with this product contains an error. the error affects the lub antigen in the first cell (donor 0124624) of the screen-cyte 0.8% and screen-cyte p 0.8% antigen panels lot 17011. specifically the table shows that cell 1 has a negative typing "0" for lub antigen while the actual value is positive "+.".