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TGA Action ID	RC-2025-RN-00842-1
Type of Product	Medical Device
Product Name/Description	RX Daytona, RX Imola and RX Modena Analysers. An in vitro medical device (IVD) RX Daytona + with ISE Catalogue: RX4040, RX4040R UDI: 05055273207774 RX Daytona + without ISE Catalogue: RX4041, RX4041R UDI: 05055273207781 RX Imola Catalogue: RX4900, RX4900R UDI: 05055273206104 RX Modena Catalogue: RX9000, RX9000R UDI: 05055273214963
ARTG Number	204222
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class III
Reason for the Action	Randox Laboratories have updated the RX Analyser manuals to include further information on maintenance and prevention of cross contamination/carryover avoidance.
Instructions for Customers/Users	Customers are to refer to the technical bulletins provided with the customer letter which contains the updated information. This action has been closed out on 24/03/2026.
Action Commencement Date	10/10/2025
Responsible Entity	Randox Australia Pty Ltd
Contact Information	02 9615 4640 - Randox Australia