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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There are three reactivity updates with respect to these kits: 1. in primer mix dpb004 (lane 4) the reactivity for the dpb1*31:01 has been updated from positive to negative. prior to this update in the presence of the dpb1*31:01 allele users may have obtained a negative reaction leading to a no-type result. 2. in primer mix dpb027b (lane 27) and dpb039a (lane 39) the reactivity for the dpb1*88:01 allele has been updated from positive to negative. prior to this update in the presence of the dpb1*88:01 allele users may have obtained a negative reaction leading to a no-type result. 3. in primer mix dpb039a (lane 39) the reactivity for the dpb1*29:01 allele has been updated from positive to negative. prior to this update in the presence of the dpb1*29:01 allele users may have obtained a negative reaction leading to a no-type result.