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 user documenation for this product is missing drb1*15:50n allele for probe on bead #525. this may generate a sample typing of drb1*15:04 instead of drb1*15:04/15:50n. there is low risk of death or serious harm to the patient orend user as a result of this potential product failure.