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 that the coulter prepplus2 failed to sense that there was no or low volume of reagent in the vial. when this occurred no reagent or insufficient volume of reagent was dispensed into daughter tubes and operator was not alerted.