| TGA Action ID |
RC-2025-RN-00587-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Ransel Glutathione Peroxidase. An in vitro diagnostic medical device (IVD).
Catalogue Numbers: RS504, RS505
UDI: 05055273205305, 05055273205312
Batch/Lot Numbers: 633340, 633346
Expiry Dates: 28-May-2026 |
| ARTG Number |
199615 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Randox Laboratories can confirm that Ransel Glutathione Peroxidase reagent, catalogue number RS504, is now discontinued along with its associated reagents: Ransel Diluting Agent catalogue number RS2318 and Haemoglobin Reagent catalogue number HG1539.
The catalogue number RS505 will remain available to purchase however it will no longer be CE marked from the 29th of July 2025. From this date the intended use of RS505 will move to research and veterinary use only and will not be submitted for IVDR. |
| Instructions for Customers/Users |
Randox Laboratories have updated the IFU for RS505 and is available on request.
This action has been closed out on 28/08/2025. |
| Action Commencement Date |
4/07/2025 |
| Responsible Entity |
|
| Contact Information |
02 9615 4640 - Randox Australia |