| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00469-1 |
| Product Name/Description |
Access 2 Immunoassay System with Software Version 3.4. An in vitro diagnostic medical device (IVD)
Affected serial numbers: 504105 and 800084 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
17/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has confirmed that Access 2 software version 3.4 has the potential to cause communication errors between the instrument and the console computer that are not recognised by the Access 2 system. If this communication error occurs, the system will halt any samples that are in-process and test results will not be imported. The clearing of the communication error cannot be resolved by the customer and the instrument will be inoperable until a service engineer performs a system restore. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
If this communication error does occur, immediately contact the Beckman Coulter representative who will perform the necessary procedures to restore the affected system. A Beckman Coulter representative will restore all Access 2 systems to the previous unaffected software version. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Service |