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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Hla fusion software version 2.0.0 sp4.1 using luminex xponent run files may generate a mis-assignment when using product(s) labtype sso dna typing tests - drb1(cat id rssoh2b1) lots 07b and 008. the hla fusion software version 2.0.0 sp4.1 may cause a conversion error on certain probes in the rssoh2b1 kits giving incorrect test results.