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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During an internal investigation of customer complaints the manufacturer has identified that customers have not used the system in the described and labelled handling instructions and have due to this inappropriate handling experienced falsely elevated blood glucose readings.
Model Catalog: 06383645119 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 05349893119 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 05367727001 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 07018975001 (Lot serial: ALL SERIAL NUMBERS)