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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Roche received a customer complaint regarding elevated imprecision and too high recovery of stfr control set level 1 and dup alarms during calibration with the reagent tq soluble transferrin receptor (stfr). the issue of elevated imprecision was confirmed by internal investigations on lot 606449 on cobas c 501 showed elevated imprecision of up to 8.9%. the other current reagent lots are not affected by this issue.