| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00488-1 |
| Product Name/Description |
Access 2 Immunoassay Systems
(Includes the Access 2 Immunoassay System and UniCel DxC 600i Synchron Access Clinical System)
An in vitro diagnostic device (IVD)
All Serial Numbers
All Software Versions |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter updated the Instructions for Use (IFU) to include the recommended temperature restrictions to address the impact of room temperature changes on certain assays run on Access 2 Immunoassay Systems. The new updated operation range temperatures are between 18 to 28 degrees Celsius. An updated version of the IFU is available on the Beckman Coulter website ( http://www.beckmancoulter.com) |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter is notifying their customers that the updated version of the Access 2 Immunoassay Systems IFU is available on the Beckman Coulter website ( http://www.beckmancoulter.com) This action has been closed-out on 19/08/2016. |
| Contact Information |
1800 060 881 - Customer Support Centre |