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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Beckman coulter has confirmed an issue where the ph test area for the gastroccult kit may display an unexpected color for a sample at a ph 7 reading when compared to the associated section of the color comparator bar. a sample with a ph 7 may exhibit a brownish-yellow color reading instead of the expected olive green color. the issue was first reported by a us account in march 2015 but the issue was escalated due to trending observed in january 2016.