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TGA Action ID	RC-2025-RN-00866-1
Type of Product	Medical Device
Product Name/Description	MAS Omni CARDIO Liquid Assayed Integrated Cardiac Control. An in vitro diagnostic medical device (IVD) Expiry date: 30/04/2027 Catalog Numbers: CDFOCRD-UL, CDFOCRD-L, CDFOCRD-101, CDFOCRD-202, CDFOCRD-303 Lot Numbers: OCRD2704U, OCRD2704L, OCRD2704, OCRD27042, OCRD27043 UDI: 00884883011946, 00884883011953, 00884883011960, 00884883011977, 00884883011984
ARTG Number	192625
Action Type	Product Alert
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	MAS Omni CARDIO Liquid Assayed Integrated Cardiac Control has been reported to have vial-to-vial variability when using the control with high sensitivity Troponin I assays. No other analytes are reported to be showing variability between vials. If there is a delay in reporting of patient results, there is a remote probability of a serious adverse event in the overall population using the device. There is no risk of incorrect results being generated.
Instructions for Customers/Users	Labs may continue to use the control if it meets their performance requirements. If the variability of the material exceeds user's laboratory’s specification, dispose of the material. Contact the Thermo Fisher Scientific Account Manager or the Customer Care Team at 1300 735 292 or email ANZcustomerservice@thermofisher.com This action has been finalised on 7/4/2026.
Action Commencement Date	13/10/2025
Responsible Entity	Thermo Fisher Scientific Australia Pty Ltd
Contact Information	1300 735 292 - Customer Care Team