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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If a reagent pack is not loaded onto access and dxi instruments in accordance with the instrument operator's guide it is possible for the instrument to pipette insufficient or incorrect reagents and generate erroneous qc or patient results.