| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01160-1 |
| Product Name/Description |
Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel 600i Synchron Access Clinical System. In vitro diagnostic medical devices (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has identified a potential problem in two pulley drive components in the mixer pulley assemblies of these systems.
It has been determined that in some cases pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts.
When these defects occur the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel.
Beckman Coulter is in the process of producing replacement components and will be installing them in every Access/Access 2 Immunoassay, SYNCHRON LXi 725 Clinical, and UniCel DxC 6001 SYNCHRON Access Clinical System in the field. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter is providing work around instructions to mitigate the risk and replacing the mixer pulley assemblies to permanently fix the problem. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |