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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Manufacturer detected a performance issue with the reagent 1 component. this issue may result in quality control values shifting out of acceptable range which is not resolved by recalibration. only replacement of the impacted lots with a new lot resolves the issue. in addition some customers have reported erratic patient results. manufacturer's investigation has determined that this issue is isolated to the 3 impacted lots.