| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00460-1 |
| Product Name/Description |
DxI 9000 Access Immunoassay Analyser. An in vitro diagnostic medical device (IVD).
REF: C11137
Multiple Serial Numbers
ARTG 177999
(Beckman Coulter Australia Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
7/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has determined that USB 2.0 cables used in the affected DxI 9000 Immunoassay Analysers could oxidise over time and negatively affect electrical conductivity.
A USB 2.0 cable with oxidised connectors may intermittently cause a loss in communication between subsystems within the analyser. The DxI 9000 Access Immunoassay Analyser may enter the red system status due to this problem and cancel all in-progress tests. The exact error displayed varies depending on the subsystem the system software was attempting to communicate with at the time.
The system software establishes communication with all subsystems during software startup. If connection is lost, the analyser cannot reestablish communication until the system software is restarted. If the system software loses connection with a subsystem and must be restarted, there may be a delay reporting patient test results which could lead to a delay in patient treatment. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
A Beckman Coulter service representative will contact users to replace parts affected by this issue.
Customers may contact their Beckman Coulter representative if ther laboratory has experienced any errors pertaining to communication failures. |
| Contact Information |
1800 060 881 - Customer Support Centre |