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 use of this product in combination with optional analysis software hla fusion software may cause misassignment to drb1*15:65 when positive reactivity is seen in well 11a. with the presence of drb4*01:03 and drb5*01:01 only a drb1*15:65 without drb1*15:01 typing result is suggested. this is due to a limitation in the software with cross loci wells. analysis of this product without hla fusion software will not generate incorrect suggested typing results.