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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The recall follows a labeling issue with one (1) lit of accu-chek rapid-d infusion sets. 66 units of lot 32114214 were wrongly re-labeled during internal re-labeling in order to comply with specific coutry requirements. only length of transfer set varies from one model to the other mislabeled. 66 units were sold in canada.