Recall of Calibrator B from ADVIA Centaur FSH Assay (used with ADVIA Centaur or ADVIA Centaur XP System). An in vitro diagnostic medical device (IVD)

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.