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TGA Action ID	RC-2025-RN-00566-1
Type of Product	Medical Device
Product Name/Description	ROTEM sigma complete and ROTEM sigma complete + hep. An in vitro diagnostic medical device (IVD) ROTEM sigma complete Part Number: 555501 Lot: S240507, S240603, S240701, S240707, S240709 ROTEM sigma complete + hep Part Number: 555502 Lot: S240607, S240608, S240706, S240708, S240804
ARTG Number	323925
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Werfen Global has identified that several lots of ROTEM sigma cartridges have a higher-than-expected likelihood of generating pressure errors during the ROTEM sigma functional checks. These functional checks take place before and after the screen notification to add a sample. If this pressure error is identified after the sample has already been inserted, it will require sample recollection. This action was undertaken prior to TGA notification.
Instructions for Customers/Users	Customers were asked to identify affected lots and return them to be replaced at no charge. This action has been finalised on 18/7/2025.
Action Commencement Date	24/06/2025
Responsible Entity	Werfen Australia Pty Ltd
Contact Information	0402689300 - João Dos Santos