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 confirmed that the advia chemistry systems hba1c method exhibits a positive bias of up to 12% for patient and cap survey samples due to over-recovery when using specific lots of a1c_3 calibrator. depending upon quality control limits this issue may not have been detected. this issue has been corrected beginning with a1c_3 calibrator lot 2ld017.