| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01101-1 |
| Product Name/Description |
Alissa Interpret
Part Number: K5849AA
Software Numbers: v5.3.7, v5.4.3
ART 285775
(Agilent Technologies Australia Pty Ltd - Information system software, application program, patient record) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/12/2023 |
| Responsible Entity |
|
| Reason/Issue |
Agilent Technologies have identified 2 issues in the software responsible for ACMG (American College of Medical Genetics and Genomics) classification scheme whereby variants are classified incorrectly.
1. The ACMG classification scheme implemented in Alissa Interpret does not result in the variant of uncertain significance (VOUS) classification when the Benign and Pathogenic variants are contradictory. The criteria for all variants are not being checked and the software stops too early when assigning a classification.
2. ACMG classification scheme implemented in Alissa Interpret does not result in the correct classification when the user-specific strength criteria are updated. It could incorrectly pick any classification. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers should
1. Examine and confirm their software version for the Alissa Interpret and their data where the affected software versions were used.
2. Note that an update to the software is being worked on and is scheduled to be released on 21DEC2023. It is recommended that customers update their software as soon as possible to resolve this error upon that release.
This action has been closed out on 09/02/2024 |
| Contact Information |
0439 100 102 - Andy Foale-Few |