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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In 2015 radiometer became aware the aqure system has a design defect regarding sample type. it is considered remotely possible that the described error by the aqure/flexlink system will cause a critical adverse event resulting in serious injury including any injury that swould require medical or surgical intervention to preclude irreversible impairment or damage.