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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Internal investigation has confirmed that primer mix b-086 found on lane 83 in the b high resolution allset gold and ssp unitray kits and on lane 9 of the b17 ssp unitray and allset gold kits gives a false negative for the b*47:03 allele according to the labeling. however the primer mix b-086 is functioning as originally designed. the b*47:03 allele has a mismatch in the primer's targeted sequence and sample specific functionality could not be confirmed through testing due to lack of sample availability.