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 has confirmed an increased number of complaints related to hemoglobin (hgb) on the unicel dxh 800 and dxh 600 coulter cellular analysis systems. the investigation has revealed that the issues may be related to variability in components of the coulter dxh diluent. the use of the dxh diluent (lot numbers 3099980 - 3512190) may eventually result in a compromised hgb chamber. the use of the dxh diluent lots listed in this notice may eventually result in a compromised hgb chamber indicated by the occurrence of events listed in the issue section. the hgb chambers are being replaced on an as needed basis. sporadic but incorrect hgb results may be observed if your system's hgb chamber is compromised. the issue is not observed with all dxh 800 and dxh 600 systems.