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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It was reported that operators/users were unable to access the accu-chek inform ii meters after a modification to an expiring certification in cobas it 1000 version more than (and equal to) 2.01.00.
Model Catalog: 04420306001 (Lot serial: Version 2.06.00); Model Catalog: 04481763001 (Lot serial: Version 2.04.01); Model Catalog: 04420306001 (Lot serial: Version 2.04.01); Model Catalog: 04481763001 (Lot serial: Version 2.06.00)