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 ids continual quality monitoring program has identified that a very small number of wash solution containers have been manufactured without adding the concentrated solution. the potential hazard associated with the use of the device is an increase in the imprecision and a bias relative to the true concentration of samples measured using the ids-isys assays on board the ids-isys analyser.