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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00598-1
Product Name/Description	ADVIA Chemistry Systems - Acetaminophen N-acetylcysteine (NAC). An in vitro diagnostic medical device (IVD). Catalogue/Lot number – SMN 10327381, all current lots (see below) and all future lots Current lots - 46251, 46564, 46369, 46370, 46619, 46782, 47001, 47157, 47558 ARTG Number: 176646
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	2/07/2015
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	Siemens Healthcare Diagnostics is issuing a field correction for a change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA Chemistry Systems Acetaminophen assay current lots and all future lots. The previous maximum NAC concentration at which acceptable acetaminophen results were obtained was 800 mg/L. Siemens has revised the concentration of NAC at which acceptable results were obtained to 200 mg/L NAC in an acetaminophen sample of approximately 661 µmol/L (10 mg/dL).
Recall Action	Recall for Product Correction
Recall Action Instructions	Siemens is advising end users of the change in the instructions for use regarding interference caused by NAC. The Instructions For Use (IFU) will be updated to reflect this change in interference.
Contact Information	1800 310 300 - Siemens Technical Support Centre