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 became aware of the following: the "calibration expiry date is 9999-12-30 (never expires) could result in incorrect handling of incoming control. frequent pop-up: "the period selected has an sd value of o". several periods may open in parallel for the same control. error codes such as "pump warning 10" and "pump warning 14" appear during initialization of the instrument.