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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Beckman coulter has identified an issue regarding the response speed on the dxh system manager for unicel dxh 800 and 600 coulter cellular analysis systems that are connected to the proservice remote management system (rms). systems connected to the proservice remote management system (rms) that have not been rebooted after processing approximately 2000 patient samples will slow down and eventually terminate processes. patient results are not affected by this issue.