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 kits will produce an incorrect typing or mistyping result of a c*07:18 allele when testing a sample which has a c*07:01:03 allele. primer mix c07-06b found on lane 42 in the cw high resolution allset gold and ssp unitray high resolution kits was found to contain a false positive for c*07:01:03. c*07:01:03 has an unknown sequence at the priming site and was incorrectly predicted to be negative in lane 42 in the kit documentation. after analysis we have confirmed that lane 42 now amplifies the c*07:01:03 allele. this discrepancy does not result in a common allele mistyping.