| TGA Action ID |
RC-2025-RN-01017-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Serology ToRCH IgM Positive Control. An in vitro diagnostic medical device (IVD).
Catalogue Number: SR10349
Lot Number: 366SR
Expiry Date: 28/04/2027 |
| ARTG Number |
354723 |
| Unique Device Identifier (UDI) |
05055273216424 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The Serology ToRCH IgM Positive Control is erroneously Negative for Herpes Simplex Virus (HSV Type 1/2 IgM) for the affected lot number.
This could result in a delay in running the quality control, and thus a delay in patient results. |
| Instructions for Customers/Users |
Customers are to:
- discontinue use of the product for Herpes Simplex Virus (HSV Type 1/2 IgM).
- If using the product for Herpes Simplex Virus (HSV Type 1/2 IgM), please contact Randox to discuss options including credit.
Randox will provide an updated IFU removing Herpes Simplex Virus 1 and 2 as a positive analyte for this product.
This action has been closed out on 09/09/2026 |
| Action Commencement Date |
9/12/2025 |
| Responsible Entity |
|
| Contact Information |
02 9615 4640 - Randox Australia |