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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This medical device recall is intended to address the following defects previously reported to health canada. these issues have been partially corrected with the release of echo software release 1.2 patch 2: - cc-09-042-02 important notification regarding echo antibody screen and id interpretations (health canada recall # 51956). - cc-10-01-001 investigation of sporadic no type determined (ntd) interpretations for hemagglutination assays on the echo (health canada recall #53353).