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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Further to complaints the manufacturer's investigation have detected a problem with certains lots of r1 reagents specificity (anti-staphylococcus aureus latex) leading to false positive results with staphylococcus non aureus strains.