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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It has been identified that ssp primer mix pmr014g incorrectly identifies the following alleles as having an expected positive reactivity: drb1*11:09/83/87/113 drb1*13:05:01-05:02/06/26:02/42/56/136. therefore the customer would see a false negative according to their documentation in the presence of any of the above listed rare alleles.