| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00350-1 |
| Product Name/Description |
Dimension and Dimension Vista Clinical Chemistry Systems. An in vitro diagnostic medical device (IVD)
Assays: Triglycerides, Enzymatic Creatinine, Automated HDL Cholesterol, Uric Acid and HDL Cholesterol
All Lot Numbers
ARTG Number: 181689 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/03/2016 |
| Responsible Entity |
|
| 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. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at significant risk for hepatotoxicity.
The potential exists for reporting falsely depressed results for the assays affected. Baseline values before administration of the NAC or Metamizole therapy would not be affected. It is extremely unlikely these assays would be requested during assessment of acetaminophen overdose and NAC treatment. |
| 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 |