Events

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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-01652-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01652-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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.

Device

Dimension Vista V-LYTE Integrated Multisensor (used for measuring Na+/K+/Cl). An in vitro diagnos...
  • Model / Serial
    Dimension Vista V-LYTE Integrated Multisensor (used for measuring Na+/K+/Cl). An in vitro diagnostic medical device (IVD).Siemens Material Number (SMN): 10484429Catalogue Number: K800ALot Numbers: All in-date lots (including future lots until further notice)ARTG number: 181686
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA