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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Some lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end range of the glucose test sensor (>400 mg/dl). specifically after a period of storage of three (3) to four (4) months the glucose sensor may report low results at the high end of the measurement range. **note: canadian distributed product was for demonstration only**.