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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