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 recall has been initiated due to an issue in icea which could result in unrecoverable loss of data when using tiered storage on icea. the issue can arise if a study has purged from tier 1 (i.E. via high water mark) and only resides in tier 2 and then the study is requested to be updated.