| TGA Action ID |
RC-2026-RN-00718-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Simplexa COVID-19 / Flu A/B & RSV Direct (MOL4450). An in vitro diagnostic medical device (IVD).
Lot numbers and Expiry dates: 24171N (31-03-2027), 24619N (31-07-2027) |
| ARTG Number |
526548 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Diasorin has identified that specific lots (24171N and 24619N) of Simplexa COVID-19 / Flu A/B & RSV Direct may fail to detect the internal control. In samples where SARS-CoV-2, influenza A, influenza B and RSV RNA are not detected, a failure in detection of the internal control may result in an invalid test result being generated. |
| Instructions for Customers/Users |
Customers are to dispose of affected lots 24171N and 24619N of Simplexa COVID-19 / Flu A/B & RSV Direct in accordance with local procedures and confirm disposal to Diasorin as outlined in the customer letter. |
| Action Commencement Date |
23/09/2026 |
| Responsible Entity |
|
| Contact Information |
1300 259 835 - Customer Service |