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 has determined that incorrect calibrator lot values were assigned for advia chemistry systems drug calibrator i lot 3jd018 for the advia chemistry systems phenytoin 2 (phny_2) and phenobarbital 2 (phnb_2) assays. this issue was determined to be the result of calibrator value miscalculation. calibrator lot 3jd018 has now been value assigned to align with the correct calibrator values. internal investigation concluded that quality control results still recover within the manufacturer's ranges when using either the incorrect or corrected calibrator values. there is no change to the calibrator values for the advia chemistry systems theophylline 2 (theo_2) assay.