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.
데이터 추가 비고
원인
Radiometer has recently become aware that the internal temperature in the aqt90 flex analyzer under worst case conditions may slightly exceed acceptable storage conditions for aqt90 flex on-board test cartridges. to ensure that the temperature does not exceed maximum limit the environmental specifications for the ambient temperature for the aqt90 flex analyzer has been adjusted to 30c/86f (down from 32c/89.6f).