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 4 issues on the unicel dxht 800 coulter cellular analysis system: 1)the system will substitute the operand 'or' within a decision rule with 'and' when the decision rule is restored and the language is not english. 2)the system will substitute the patient age unit (days months years) within a decision rule with an empty string when the decision rule is restored and the language is not english. 3)the diagnostic procedure simulate-cdnr cycle is not returning the system to correct sample processing state. 4)the auto prune function is deleting quality control files.