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TGA Action ID	RC-2025-RN-00531-1
Type of Product	Medical Device
Product Name/Description	RX Analysers. An in vitro diagnostic medical device (IVD). Catalogue numbers: RX4040, RX4040R, RX4041, RX4041R, RX4900, RX4900R, RX9000, RX9000R, RX5000, RX5000R, RX6015, RX6015R. UDI numbers: 05055273207774, 05055273207781, 05055273206104, 05055273214963, 05055273207750, 0505527321535.
ARTG Number	204222
Unique Device Identifier (UDI)	See supporting information
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Analyser manuals have been updated to remove references to compliance with the EU directive 98/79/EC and replaced with “In vitro diagnostic devices are designed and developed in compliance to the regulations and country requirements listed in the regulatory assessment”. Randox Laboratories has also incorporated RX carryover avoidance information into the operator manuals for the RX Imola, RX Daytona + and RX Modena analysers.
Instructions for Customers/Users	Customers are to note that: · Randox laboratories has updated analyser manuals to replace references to EU directive 98/79/EC with a statement confirming that the in vitro diagnostic devices are designed and developed in accordance with applicable regulations and country specific requirements. · Randox Laboratories has updated relevant analyser manuals to include carryover avoidance information for the RX series analysers. · Updated Technical Bulletins will be made available in PDF format and individual page updates can be provided upon request. This action has been closed out on 22/12/2025
Action Commencement Date	6/06/2025
Responsible Entity	Randox Australia Pty Ltd
Contact Information	02 9615 4640 - Randox Australia Office