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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The use of microalbumin calibrator lot 7hd049 will result in poor calibration and unacceptable recovery of quality control. quality control elevations as high as 50% seen at albumin concentrations of 10mg/ml.