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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Internal investigation identified a trend of three complaints regarding lanes 27 and 39 giving false negative results for a dpb1*126:01 allele. the primer mixes within lanes 27 and 39 target regions of the dpb1*126:01 allele which are undefined. currently there are qc comments provided with the kit about the primers in the affected lanes stating that they have predicted reactivity. the dpb1*126:01 allele reactivity is assigned according to the common alleles. the primer mixes have not been tested with a dpb1*126:01 sample the labeling stated the primers in lanes 27 and 39 would amplify the targeted sequences in the dpb1*126:01 allele.