| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01116-1 |
| Product Name/Description |
ADVIA Centaur and ADVIA Centaur XP (An in vitro diagnostic medical device (IVD))
Multiple Catalogue Numbers
Bulk Fluid Reserve Assembly (Acid & Base)
Siemens Material Numbers: 10282187 & 10483525
Wash 1 Reservoir Connector
Siemens Material Numbers: 10364516 & 10483526
ARTG Number: 175890 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has identified an issue that on some systems a slight cracking of the tubing (the tubing for the Wash 1, acid, and base bottle reservoirs) at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress. The cracking may result in a minor drip of fluid onto the reservoir and into the drip tray located underneath the reservoirs. The potential for minimal fluid leakage outside the system exists. The drip will cause the reservoir to empty faster than the system expects. Once the acid and base fluids are depleted, the system detects it and will flag all subsequent results with a signal error flag, once the lack of acid/base solution is detected. When Wash 1 fluid becomes low, the system will detect it and stop processing samples. In this case, a limited number of test results (up to 20 tests) processed prior to a signal error may be affected and not flagged. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising the customers to examine their system to see if there is any fluid in the reservoir drip tray. If fluid is present, the customer is advised to contact their Siemens Customer Care Center or local Siemens technical support representative to schedule a visit. Until a service engineer has inspected their system for this issue, Siemens recommends that the customers replace the bulk bottle for all fluids immediately when the yellow warning appears. This will help mitigate the possibility of improper fluid dispenses. Siemens service engineers will inspect the tubing on the next service visit and replace the tubing if necessary. This action has been closed-out on 11/08/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Center |