Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-01227-1
Product Name/Description	AMH Gen II ELISA (clinical chemistry substrate, Anti-Mullerian Hormone assay). An in vitro diagnostic medical device (IVD). Part number: A79765 All lot numbers are affected ARTG number: 185654
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	5/12/2012
Responsible Entity	Beckman Coulter Australia Pty Ltd
Reason/Issue	Beckman Coulter has confirmed through customer feedback and internal investigation that some samples diluted with the AMH Gen II Sample Diluent prior to running the assay may generate results that are falsely elevated.
Recall Action	Recall for Product Correction
Recall Action Instructions	Beckman Coulter is providing updated work around instructions to mitigate the issue and asking users to notify clinicians/research scientists regarding the potentially affected results at the discretion of the Laboratory Director.
Contact Information	1800 060 881 - Beckman Coulter Customer Support Centre