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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The a19 allset gold ssp kit has a false negative in lane 30 for the a*74:06 allele that will cause a no typing result. internal investigation has confirmed that primer mix a 74-01 found on lane 30 in the a19 allset gold and ssp unitray kits gives a false negative for the a*74:06 allele according to the documentation within the kits. however the primer mix a 74-01 is functioning as originally designed. a human error resulted in a manual change of the a 74-01 primer mix to be listed as positive for the a*74:06 allele within kit documentation and the kit .Uch file.