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 healthcare diagnostics has identified two issues with affected lots of dimension vista hemoglobin a1c (hba1c) flex reagent cartridges. for hba1c values below 6% a positive bias of approximately 0.3% has been observed. there is also a higher frequency of 'above assay range' flags with these lots.