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TGA Action ID	RC-2025-RN-00718-1
Type of Product	Medical Device
Product Name/Description	EliA ANA Positive Control 250 and EliA ANA Positive Control 2500. An in vitro diagnostic medical device (IVD). EliA ANA Positive Control 250 Material Numbers: PU 83-1033-01, PU 83-1033-41 Lot/Serial Numbers: U1K9/C9RG7, TZUR /C9RG7, U5U7/C9RG8, U4FC/C9RG8, U3DU/C9RG8, U6R0/C9RG9, U4N9/C9RG8 EliA ANA Positive Control 2500/5000 Material Number:PU 83-1073-01 Lot/Serial Numbers: U1FZ/CMJG7, U4PC/CMJG8
ARTG Number	229585
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class III
Reason for the Action	An investigation of EliA ANA Positive Control 250 and EliA ANA Positive Control 2500/5000 has shown that the acceptance ranges for EliA dsDNA and EliA Ro60 on the control certificates were not correct. New ranges are being provided.
Instructions for Customers/Users	Customers should read the customer letter carefully as it contains the updated acceptance ranges. Customers should also note that here is no alternative stock is available currently. Customers may therefore receive affected stock, however it will be supplied with the customer letter that contains the updated acceptance ranges. Alternative unaffected stock is expected to be available in approximately 1 month This action has been closed out on 21/11/2025.
Action Commencement Date	15/08/2025
Responsible Entity	Abacus dx Pty Ltd
Contact Information	1800 222 287 - Abacus dx Customer Care