| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00697-1 |
| Product Name/Description |
UniCel DxC ISE Reference reagent tubing
UniCel DxC 600/800 - All models |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has identified a failure of the UniCel DxC ISE tubing (Lines 11, 25 and 26) for ISE Reference reagent.
The failure occurs due to the interaction between a new tubing plasticiser and the ISE Reference reagent. The supplier's change in plasticiser was due to a move to a phthalate-free tubing material based on new environmental regulations.
As a result, a visible slow-forming non-microbial white material may appear inside the tubing.
This may result in suppressed ISE quality control and patient results due to Reference Drift errors and/or ISE calibration failures and/or tubing lines 25 or 26 detaching due to obstruction of flow. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are requested to immediately perform a visual inspection of ISE Reference reagent tubing 11, 25, and 26 for the white material and in cases where material is identified a workaround is provided. In the longer term, Beckman Coulter is qualifying new ISE tubing and laboratories will be notified when new tubing is available to be installed on instruments subject to this Recall. This action has been closed-out on 02/05/2017. |
| Contact Information |
1800 060 880 |