| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00402-1 |
| Product Name/Description |
AU2700/AU2700 Plus and AU5400 Clinical Chemistry Analysers, an in vitro diagnostic medical device (IVD)
(Customers with modifications AU2700-184, AU5400-190 Complete)
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter implemented a redesigned detergent tube, replacing the tubing with a more pliable material to allow for easier insertion to the detergent tank. New complaints that the joint connecting the tubing is disintegrating over time have been received. Disintegration of the tubing/joint has the potential to result in detergent leaks. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter has requested their customers to implement work around maintenance procedures until a new tubing design can be implemented. Customers are also requested to discontinue use of the analyser and contact Beckman Coulter immediately if a leak occurs. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Service Centre |