| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00724-1 |
| Product Name/Description |
Access Thyroglobulin Reagent Kit. An in vitro diagnostic medical device (IVD)
For use with the Access Family of Immunoassay Systems including 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.
Product REF - 33860
Lot Number:
430969
431990
434727
522896
523251
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
The Access Thyroglobulin reagent pack lots may generate falsely elevated results at concentrations <10 ng/mL. The estimated maximum magnitude of the potential error in the affected range is a shift of up to 0.36 ng/mL high at concentrations <10 ng/mL. Acceptable total imprecision was observed at values of 10 ng/mL and higher. |
| Recall Action |
Recall |
| Recall Action Instructions |
Beckman Coulter is requesting their customers to discard all Access Thyroglobulin reagent pack from the affected lots. Retesting should be carried out at the discretion of the laboratory director. This action has been closed-out on 26/08/2016. |
| Contact Information |
1800 060 881 - Customer Support Centre |