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
The freestyle blood glucose test strips when used with the freestyle blood glucose meter built into the omnipod insulin management system may produce erroneously low blood glucose results. erroneously low results that are not recognized may pose significant risks to a user's health.
Model Catalog: CAT45F (Lot serial: All lots); Model Catalog: PDM-CAT35E (Lot serial: All lots); Model Catalog: PDM-CAT35F (Lot serial: All lots); Model Catalog: CAT45E (Lot serial: All lots)