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
The coulter prepplus may experience intermittent reagent level sense failures where the instrument may not produce a warning that a reagent vial is low or out of reagent. this failure will result in incomplete or no antibody dispensed into the daughter tube with a potential for erroneous but credible results.