| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00458-1 |
| Product Name/Description |
Dimension Troponin 1 (TNI) & Dimension Vista Digoxin (DIGXN), Estradiol (E2), Ferritin (FERR), Prolactin (PRL) & Thyroid Stimulating Hormone (TSH) assays. An in vitro diagnostic medical device (IVD).
Multiple Catalogue and Siemens Material Numbers (SMN)
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 |
11/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has confirmed that the concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vista Instructions For Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, TSH have incorrect units, and incorrectly state the level at which biotin does not interfere. In the cases of TNI, E2, FERR, PRL, and TSH, there is significant interference at the levels incorrectly stated in the current IFU. Dimension Vista E2, a competitive assay, exhibits a positive bias while the other methods (sandwich assays) exhibit a negative bias. DIGXN SI units for Biotin are incorrect by a factor of 100 lower than the level at which biotin does not interfere, in the current IFU.
The probability of misinterpretation of results is remote, and would be limited to when a patient taking biotin supplements in excess of the daily recommended allowance has a blood sample drawn before biotin is cleared to a level that does not interfere with testing. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users of the correct biotin interference levels for the affected assays. This information should be reviewed with the laboratory Medical Director. In future, Siemens will be updating the IFU with the correct levels.
This action has been closed out on 21/02/2019 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |