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.
데이터 추가 비고
원인
The current glucm (glucose modular) assay is not capable of reporting accurate results below 10mg/dl on both the lx and dxc systems. there is no discernable trend and the magnitude of the discrepancy is variable. glucm (glucose modular) assay is utilized on plasma serum urine and csf samples. the current sensitivity claim for the assay is 3 mg/dl for all sample types.