| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01652-1 |
| Product Name/Description |
Dimension Vista V-LYTE Integrated Multisensor (used for measuring Na+/K+/Cl). An in vitro diagnostic medical device (IVD).
Siemens Material Number (SMN): 10484429
Catalogue Number: K800A
Lot Numbers: All in-date lots (including future lots until further notice)
ARTG number: 181686 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed a low bias for Dimension Vista V-LYTE Integrated Multisensor urine potassium (K) when compared to the Dimension QuikLYTE Integrated Multisensor, which is the predicate device used in the method comparison section of the V-LYTE Instructions for Use (IFU). Testing by Siemens showed a bias of -4.9% at a urine potassium concentration of 39.6 mmol/L, -19.6% at a urine potassium concentration of 32.8 mmol/L, and an average bias of -10.9% over the urine potassium concentration range of 7.5 to 133.7 mmol/L. This bias affects patient results, QC and could result in failures in accuracy-based proficiency testing programs. The risk to health as a result of the bias is negligible.
Serum/plasma potassium results are not affected by this issue as there are separate parameters for serum/plasma potassium. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens will be updating the internal coefficients for urine potassium in a future version of the Dimension Vista software. In the interim, Siemens recommends entering the following comparison coefficients for urine potassium to compensate for the observed bias: Urine Potassium: C0 = -1.03, Urine Potassium: C1 = 1.14. These correlation factors are to be applied for urine samples only. Siemens is not recommending a review of previously generated results.
This action has been closed out on 11/07/2019 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |