Dimension Vista V-LYTE Integrated Multisensor (used for measuring Na+/K+/Cl). An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2016-RN-01652-1

Class II

2016-12-21

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01652-1

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.

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.