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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Siemens has received complaints regarding barcode scanning issues with the dca hemoglobin a1c cartridges. internal investigations have confirmed that cartridge barcode integrity issues are causing unsuccessful scans and preventing testing on the dca systems. this issue has been isolated to two lots of dca hba1c kits.