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 confirmed high platelet background counts during start up on coulter hmx analyzers with some containers of coulter isoton iii diluent lot 50752f. the issue was initially reported by a laboratory in the us on 2014 march 10. the customer reported recurring high platelet background counts on the coulter hmx hematology analyzer. there has been no report of death or injury related to this defect.