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
Siemens has confirmed customer complaints of falsely depressed creatinine results when dimension clinical chemistry systems enzymatic creatinine (ezcr) reagent is processed from open wells that are in close proximity to open wells of dimension clinical chemistry systems phosphorus (phos) reagent. both quality control and patient samples may be affected.