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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One complaint regarding this issue has been received. complaint states the b*35 aiiset gold ssp kit has a false negative in lane 8 which gives no perfect match typing result for the b*35:116 allele. internal investigation has confirmed with the now available rare sample type that lane 8 is negative for the b*35: 116 allele in the above listed affected kits according to the labeling provided with the kits. the primer mixes had not been tested with a b*35: 116 sample the labeling stated the primers in lane 8 would amplify the targeted sequences in the b*35: 116 allele.