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 regarding this issue has been received. complaint states the drb1*04 ssp unitray kit has a false negative in lane 9 which gives no perfect match typing result for the drb1 *04:32 allele. internal investigation has confirmed with the now available rare sample type that lane 9 is false negative for the drb1 *04:32 allele in the listed affected kit according to the labeling provided with the kit. product does not meet specification. however the primer mix in lane 9 is functioning as originally intended. the drb1*04:32 allele has a mismatch in the primer's targeted sequence and sample specific functionality could not be confirmed through testing.