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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Primer mix pm169a contained in the named kits may produce a weak true positive band at the correct base pair size of 135bp. the primer mix is designed to detect b*15 alleles. the problem of a weak true positive signal could mean that a test would have to be repeated.