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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As a result of a complaint and subsequent investigation a software defect was detected that affects all versions of quanta-lyser software when processing eia assays in duplicate only. results reported from the quanta-lyser using quanta link data management software are not affected.