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 determined that calibrator values (data/calibration mathematics) for vitros fs calibrator 1 lot 91461 are not available for selection on the assay data diskettes drvs 5904 through 5910. vitros fs calibrator 1 is used on vitros systems to calibrate the following assays: vitros amph aso barb benz cocm d%a1c dldl hscrp pcp rf and thc reagents.