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
Recall initiated due to observed trend which may cause the potential for false positive results. internal testing confirmed the kit performance is meeting performance claims. ebv-igm results should not be used alone but in conjunction with other ebv serological markers to determine disease state.