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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Immucor has indicated that additional testing of cell ii (donor c5716) has determined that the donor is le(b) negative instead of le(b) positive as indicated on the master list included with the product. therefore panoscreen i and ii (lot 01888) does not include a le(b) positive red cell. this carries a risk for anti-le(b) to go undetected.