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.
데이터 추가 비고
원인
A limited number of sealed test strip vial boxes from certain blood glucose test strip lots may include an open test strip vial. test strips contained within open vials are exposed to the outside environment which can affect strip performance. in particular test strips exposed to the environment may provide incorrect low blood glucose results. inaccurate low blood glucose results may lead to undetected hyperglycemia (high blood glucose) and result in improper treatment.