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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01012-1
Product Name/Description	ISE Reference Solenoid Valve for AU400, AU480, AU640, AU680, AU2700, AU5400 and AU5800 Chemistry Analysers. An in vitro diagnostic medical device (IVD) (clinical chemistry analysers) Part Numbers: MU3226 and MU7638 All model numbers affected ARTG Number: 177999
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	1/10/2013
Responsible Entity	Beckman Coulter Australia Pty Ltd
Reason/Issue	Beckman Coulter has confirmed that some ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected. Affected results may be clinically significant (high or low) and may impact patient diagnosis and/or treatment.
Recall Action	Recall for Product Correction
Recall Action Instructions	Beckman Coulter is providing users with instructions on how to inspect tubing for the presence of air bubbles. Where air bubbles are present, users are to contact Beckman Coulter for a replacement valve. Beckman Coulter is recommending consulting the laboratory director to determine the impact of this issue and if a retrospective review of prior results is necessary. As a preventative measure, Beckman Coulter is proving work around instructions for users to follow until a replacement ISE valve is implemented.
Contact Information	1800 060 881 - Beckman Coulter Customer Support Centre