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 reagent lots 248511 and 265219 of elecsys anti-hav may cause failed calibrations if used on the modular analytics e170 cobas e 411 or cobas e601/602 analyzers.