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 has been received. drb1 high res ssp unitray kits have a false negative in lane 44 for drb1*04:33 allele. internal investigation confirmed by sequence based typing that the customer had a drb1*04:33 allele. therefore lane 44 has a confirmed false negative in the affected kits according to the labeling. however the primer mix in lane 44 is functioning as originally designed. the drb1*04:33 allele has a mismatch in the primer's targeted sequence and sample specific functionality could not be confirmed through testing.