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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Ortho clinical diagnostics (ocd) was notified by a proficiency testing agency that results using vitros chemistry products valp reagent were negatively biased compared to other manufacturers. ocd performed an internal investigation and confirmed that patient results are also affected by this issue. as a result ocd will be adjusting the calibrator values for vitros valp reagent.