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 primer mix in lane 6 (primer mix r13-51b) of the affected products may cause a drb1*13:50 allele to be typed as a drb1*13:14 allele. these alleles occur very rarely. this issue is due to limited sequence information available for this allele at the time of release. due to the recent availability of a sample exhibiting the drb1*13:50 allele a new lot-specific comment has been added to the quality control comments alerting users to the possbility of a false negative in lane 6 with the drb1*13:50 allele.