| TGA Action ID |
RC-2025-RN-00921-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
LIAISON C. difficile Toxins A&B Assay. An in vitro diagnostic medical device (IVD)
Product Code: 318900
Lot: 137454
Expiry date: 27/02/2026 |
| ARTG Number |
193687 |
| Unique Device Identifier (UDI) |
08056771600477 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The affected product LIAISON C. difficile Toxins A&B, lot 137454, has the potential for false positive patient test results on some samples. |
| Instructions for Customers/Users |
Customers should note that Use of the lot may continue. However, to mitigate the risk, positive test results should be confirmed using an alternative method.
Review of past patient test results is not recommended. The risk to patients is low. Some positive results from the affected test lot may be false positives, but others may be correct.
A new unaffected LIAISON C. difficile Toxins A&B (318900) lot is currently being shipped. Diasorin will notify you as soon as it is available.
This action has been closed out on 26/02/2026 |
| Action Commencement Date |
27/10/2025 |
| Responsible Entity |
|
| Contact Information |
0477 484 111 - Nam Nguyen |