| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00369-1 |
| Product Name/Description |
Access 2 Family of Immunoassay Systems. An in vitro diagnostic medical device (IVD)
Access 2, Access 2, Re-manufactured and the UniCel DxC 600i SYNCHRON Access Clinical Systems
Reference Numbers: 81600N, 386220, A25637, A25638
Multiple Instrument Serial Numbers
ARTG Number: 177999 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
It has been determined that a circuit board that controls motor functions in specific instrument systems can affect device positioning on the pipettor and incubator belt while the instrument is running. Users may experience the following errors that may cause a delay in the reporting of patient results:
- An incubator belt motion error which can result in the instrument going into the Not Ready mode and cancellation of all in-process tests; and/or
- Z pipettor motion errors which can result in cancelled tests.
In the worst case scenario, the potential harm would be a delay in patient diagnosis and/or treatment, with a potential worst case severity of permanent injury. The probability of harm for this event is unlikely. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter (BC) is advising users to adhere to the following interim instructions. If you experience:
- z pipettor motion errors, to re-run any cancelled tests; and/or
- incubator belt motion errors.
please review the associated event on the ‘Event Log’ screen and follow the troubleshooting instructions provided. Users are further advised that they will be contacted by their BC service representative to schedule a visit to replace the circuit board on their instruments as a permanent fix.
This action has been closed out on 21/09/2018 |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |