| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00490-1 |
| Product Name/Description |
UniCel DxI Immunoassay Systems
(Includes the UniCel DxI 600 and UniCel DxI 800 Access Immunoassay Systems; and the UniCel DxC 660i,
UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i Synchron Access Clinical Systems)
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 incude the recommended temperature restrictions to address the impact of room temperature changes on certain assays run on UniCel DxI Immunoassay Systems. The new updated operation range temperatures are between 18ºC to 28ºC. 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 UniCel DxI Immunoassay Systems IFU is available on the Beckman Coulter website ( http://www.beckmancoulter.com) This action has been closed-out on 20/04/2017. |
| Contact Information |
1800 060 881 - Customer Support Centre |