| TGA Action ID |
RC-2026-RN-00263-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
RX Daytona +. An in vitro diagnostic medical device (IVD)
RX Daytona + with ion selective electrodes (ISE) & RX Daytona + without ISE
Catalogue Numbers: RX4040, RX4040R, RX4041, RX4041R
Serial Numbers: 7241-0801 and after |
| ARTG Number |
204222 |
| Unique Device Identifier (UDI) |
05055273207781 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Randox Laboratories have updated the RX Daytona + analyser manuals to remove references to the European Commission Representative and include new equipment label information.
For analysers with serial number 7241-0801 and after, the reference to the European Commission Representative has been removed and a Limited Lifetime 7 Years symbol has been added to the device’s label, showing that the device has a limited lifetime of 7 years. There has not been any change to the lifetime of the analyser. |
| Instructions for Customers/Users |
Randox Laboratories will provide the updated sections of the manual along with a complete soft copy of the manual.
Customers are to:
- Update their RX Daytona + analyser manuals following the technical bulletin information RXTB-0174.
This action has been closed out on 18/05/2026 |
| Action Commencement Date |
15/04/2026 |
| Responsible Entity |
|
| Contact Information |
02 9615 4640 - Randox Australia |