| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01042-1 |
| Product Name/Description |
Access Free T3 Reagent Kit (For use with the Access Family of Immunoassay Systems). An in vitro diagnostic medical device (IVD)
The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems
Catalogue Number: A13422
Lot Number: 431433
ARTG Number: 213976 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has determined that some Access Free T3 reagent packs were filled incorrectly. Beckman Coulter has determined and confirmed that thirty-two Access Free T3 reagent packs are affected by this issue.
These packs contained insufficient quantity of reagents in one or more of the pack wells. This may give rise to inaccurate test results and/or delays in therapy.
There has been no report of death or injury related to this defect. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are asked to discard affected lots numbers and to initiate a review of patient results as per the discretion of the Medical Director. This action has closed-out on 19/08/2016. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |