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 determined that the use of affecteed lots of the coulter dxh diluent may be associated with elevated platelet (plt) background counts between 3-7 x 10^3 cells/ul that will result in failed daily checks on the unicel dxh 800 and dxh 600 coulter cellular analysis systems.