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
Ortho clinical diagnostics (ortho) has initiated this recall in regard to a software anomaly where the tcautomation software may send incorrect information to a vitros system through the inout communication interface. this event can cause an unintended sample to be moved into the bypass aspiration position and aspirated and results to be misassociated with the wrong patient sample id without the operator being notified. the inout communication interface is currently used by all engen systems.