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
Mfg initiated the recall. the control organisms are not properly fixated on the slide which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain. this contamination could potentially lead to misdiagnosis and improper treatment of a patient.