| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00079-1 |
| Product Name/Description |
Automated 2500 Family Systems
Models:
ODL25120 AutoMate 1200
ODL25125 AutoMate 1250
ODL25250 AutoMate 2500
ODL25255 AutoMate 2550
ARTG: 177999 (Beckman Coulter Australia Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
13/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has identified a potential issue, where belts on the x-axis (and on the y-axis, to a lesser extent) are showing premature failure and breaking. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Beckman Coulter will be in contact with affected users to arrange replacement of the affected belts by a service technician.
This action has been closed out on 09/07/2019 |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |