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 received customer complaints regarding the dimension enzymatic creatinine (ezcr) flex reagent cartridge. siemens recently confirmed an issue which may cause ezcr elevations across the assay range. this issue may or may not be detected by quality control as the degree and onset of elevated results may vary and is likely dependent on multiple factors such as method mix or instrument maintenance.