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
Siemens healthcare diagnostics has confirmed through internal investigation that the advia centaur systems cyclosporine dheas folate and ahbcm assays are susceptible to biotin interference. this occurs when biotin present in patient samples interferes with the biotin-streptavidin assay architecture on the advia centaur platforms. biotin interference has the potential to bias analytical results on these assays.