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 each issue has been received. complaint states the dpb1 ssp unitray kit has a false negative in lane 30 which gives no perfect match typing result for the dpb1*29:01 allele. internal investigation has confirmed with the now available rare sample type that lane 30 is negative for the dpb1 *29 :01 allele in the listed affected kits according to the labeling provided with the kits. the primer mixes had not been tested with a dpb1 *29:01 sample the labeling stated the primers in lane 30 would amplify the targeted sequences in the dpb1 *29:01 allele.