| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01044-1 |
| Product Name/Description |
AU480, AU680, AU5800 Chemistry Analysers. An in vitro diagnostic medical device (IVD)
Part Numbers: MF7311 C cup
Various Model Numbers
All products manufactured since March 2011
ARTG Number: 236636 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
17/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
The C cup may crack due to stress (e.g., wear during use), which may lead to coolant leaking from the cup.
For CF150420-069 (customer complaint), the C cup cracked and leaked coolant onto the connectors of the PCB underneath the C cup. This resulted in a short-circuit of the PCB and smoke. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter is inspecting all analysers and will replaced any affected cups.
This action has been closed-out on 23/03/2018. |
| Contact Information |
1800 060 881 - Customer Support Centre |