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 reason for the recall is related to a situation where the manufacturer has identified during an internal investigation that the substance fulvestrant may lead to falsely elevated results in the elecsys estradiol ii and elecsys estradiol iii assays.