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
Beckman coulter received a report from a customer in ireland that the creatinine assay generated erroneously low creatinine results for patient samples and qc samples. the most probable cause of this issue is calibration drift due to uptake of atmospheric carbon dioxide (co2) by a small volume of residual reagent in the creatinine reagent vial.