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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00348-1
Product Name/Description	ADVIA Chemistry Systems (using Trinder and Trinder-like assays). An in vitro diagnostic medical device (IVD) Assays: Cholesterol_2, Cholesterol_c, Enzymatic Creatinine_2, Glucose Oxidase, Triglycerides_2, Triglycerides_2 concentrated, Uric Acid, Uric Acid concentrated reagents, Fructosamine. LDL Cholesterol Direct, Direct HDL Cholesterol, Glucose Oxidase, Concentrated reagents. All Lot Numbers ARTG Number: 176642
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	24/03/2016
Responsible Entity	Siemens Healthcare Pty Ltd
Reason/Issue	Siemens Healthcare Diagnostics has become aware of N- Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. The Trinder reaction is a reaction where hydrogen peroxide is formed and subsequently reacts with a phenol derivative and aminoantipyrine in the presence of peroxidase to form a coloured quinone product. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N- Acetylcysteine (NAC) or Metamizole. Baseline values before administration of the NAC or Metamizole therapy would not be affected.
Recall Action	Recall for Product Correction
Recall Action Instructions	Siemens is advising the IFUs for the relevant assays will be updated to indicate that "Venipuncture should occur prior to Metamizole/N-Acetyl Cysteine (NAC) administration due to the potential for falsely depressed results." A review of previously generate results is at the discretion of the Laboratory Director. This action has been closed out on the 27/09/2018.
Contact Information	1800 310 300 - Siemens Technical Solutions Centre