| TGA Action ID |
RC-2025-RN-00582-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Alissa Interpret Software
Part number: K5849AA
Affected software versions: 5.2.4, 5.2.6, 5.2.7, 5.2.10, 5.2.11, 5.3.2, 5.3.3, 5.3.4 |
| ARTG Number |
285775 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Duplicated entries of managed variants in Managed Variant Lists may lead to inconsistent triage of variants (when using an MVL filter) and matching visualisation in analysis.
However, the problem has been resolved since August 2023 and duplicate entries are no longer possible.
Nevertheless, historical entries in the MVL list contain duplicate entries that may not have been but should be addressed. |
| Instructions for Customers/Users |
1. Customers should review their MVL data for duplicate entries and confirm the correct variant and archive the extra copies.
2. Customers should repeat Step 1 for all variants that have duplicate entries within Alissa Interpret.
3. Customers can reach out to informatics_support@agilent.com to receive a copy of affected variants in MVL.
This action has been finalised on 2/10/2025. |
| Action Commencement Date |
22/07/2025 |
| Responsible Entity |
|
| Contact Information |
+61 3 9566 1723 - Enia Lucia Kakaflikas |