| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01350-1 |
| Product Name/Description |
Various Dimension and Dimension Vista LOCI Assays. An in vitro diagnostic medical device (IVD)
Thyroid Stimulating Hormone (TSHL)
LOCI Free Thyroxine (FT4L)
Thyroid Stimulating Hormone (TSH)
Cardiac Troponin I (CTNI)
Mass creatine kinase MB isoenzyme (MMB)
Sirolimus (SIRO)
Multiple Catalogue Numbers and SMNs (see attached)
All Lots (including all future lots until the IFU is updated)
ARTG Numbers: 182774, 182220, 180109 & 181687 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
In March 2017, Siemens Healthcare issued an Urgent Recall for Product Correction VC 17-04 (TGA Ref: RC-2017-RN-00458-1) regarding incorrect units for biotin listed in the Non-Interfering Substances section of select Instructions for Use in Dimension and Dimension Vista assays.
The ongoing investigation by Siemens has identified the following new information regarding biotin interference:
1. Biotin interference limits are incorrectly listed in the Instructions for Use (IFU) for the affected assays. These concentrations of biotin can potentially result in interference >10%; and
2. The Dimension Vista CTNI, MMB, and Dimension SIRO method IFUs do not contain biotin interference information. Concentrations of biotin can potentially result in interference >10%.
Siemens is continuing to investigate biotin interference with our assays and more information will be forthcoming. The probability of misinterpretation of results due to this issue is unlikely.
|
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users of the correct biotin interference levels for the affected assays. A lookback of previously generated results is not recommended.
This action has been closed out on 21/02/2019 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |