| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01087-1 |
| Product Name/Description |
Small Form Factor Console PC (Used Access 2 Immunoassay System and the UniCel DxC 600i SYNCHRON Access Clinical System). An in vitro diagnostic medical device (IVD)
Ref.: B23083 (small PC with silver faceplate) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has determined that the Access 2 Console PC (B23083) may experience an “MFC Exception” error during normal operation. If this error occurs, the system will exit the Access 2 User Interface (UI) screen and display a window that notifies the user of a “0==iTubeScanCount” event. If the UI is re-launched, the system will prevent access to the Sample Manager screen to request samples for processing and the same “MFC Exception” error will occur. The Access 2 Console PC UI error can cause a delay in reporting of results, but will not cause erroneous results. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter service representative will contact affected customers and schedule a service visit to modify their Console PC. In the interim, customers are advised to continue operating their systems normally and contact Beckman Coulter Customer Support Centre if the error occurs. This action has been closed-out on 20/04/2017. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |