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.
데이터 추가 비고
원인
One complaint regarding this issue has been received. complaint states the dpb1 ssp unitray kit has a false negative in lanes 27 30 and 39 which gives no perfect match typing result for the dpb1*53:01 allele. internal investigation has confirmed with the now available rare sample type that lanes 27 30 and 39 are negative for the dpb1*53:01 allele in the above listed affected kits according to the labeling provided with the kits. however the primer mixes in lanes 27 30 and 39 are functioning as originally intended. the primer mixes within lanes 27 30 and 39 target regions of the dpb1*53:01 allele which are undefined.