| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00748-1 |
| Product Name/Description |
Recapper for the AutoMate 2500 Family. An in vitro diagnostic medical device (IVD).
ODL25250 AutoMate 2500
ARTG Number: 177999 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has identified there is a potential that a component on the recapper Module did not have the required coating specified for that part.
The coating on the recapper component helps to ensure both the longevity of the part, and help the gripper to release the parafilm so it properly seals to the tube.
If there is an uncoated component on your recapper, this could lead to the tubes not being properly sealed. In the worst case scenario, this could cause sample cross contamination and subsequent misdiagnosis. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter will schedule a time to visit affected users to confirm whether the proper coating on the recapper component is present, and replace the component. In the interim, users are advised that no action is required on their part.
This action has been closed out on 01/11/2018 |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |