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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Opti medical investigated a report from the field where an opti cca-ts2 was found to measure thb high in whole blood. internal investigation has reproduced this finding showing a positive bias in thb results in whole blood when saturated oxygen (so2) is low. this issue was found on all opti blood gas analyzers manufactured after july 2009.