UniCel DxI Immunoassay Systems(Includes the UniCel DxI 600 and UniCel DxI 800 Access Immunoassay Systems; and the UniCel DxC 660i,UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i Synchron Access Clinical Systems)An in vitro diagnostic device (IVD) 의 리콜

Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.