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 three problems with the unicel dxh 800 coulter cellular analysis system: problem # 1: differential percentages results transmitted to the lab information system (lis) may not add to 100.0 or 100.00%. problem # 2: there was an increased rate of unexpected default test orders due to failure to accept test orders from the lis. problem # 3: 6c and retic-x were mislabeled in the transmission string to the lis.