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 received an increased number of customer complaints observed after s-cal calibration on the unicel dxh 800 and dxh 600 coulter cellular analysis systems and the coulter lh 750 and lh 780 hematology systems. customers have reported a variety of issues during calibration including: an increase in h&h check messages low mch recover in xb and low mchc recovery in xb. these issues are not observed with all analyzers.