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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Complaints received regarding iron calibrations outside of acceptable calibration slope (m) values (0.97-1.03) when using iron calibrator lots 2dn060 and 2fn063. lots 2gn068 and 2jn074 may also be impacted but no complaints received.