| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00174-1 |
| Product Name/Description |
Rotor Yokes (used in Allegra X-5 Centrifuge). An in vitro diagnostic medical device (IVD)
Rotor Yokes Part Number: B30593
Lot Numbers: 322/13 and 355/13
ARTG Number: 177999 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
A defective rotor yoke allows improper rotor seating on the hub resulting in possible rotor failure if the buckets are loaded in an imbalanced configuration.
If the rotor becomes unbalanced it may vibrate excessively and/or exhibit smoke if the rotor is rubbing inside the centrifuge.
There is a chance of physical injury to users as a result of the vibration if the issue occurs. There is also a remote risk of a delay in results if the failure occurs. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter is replacing the affected rotor yokes. The centrifuge can continue to be used, as long as all runs are balanced appropriately. This action has been closed-out on 07/09/2018. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |