Events

Recall of V-Lyte Dilution Check & V-Lyte Integrated Multisensor Technology (IMT). 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-2017-RN-00533-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00533-1
  • 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 two issues related to the v-lyte integrated multisensor technology (imt) system. the issues regarding the v-lyte dilution check solution and the v-lyte imt system are:1. dilution check relative bias failures - a high rate of dilution check relative bias failures of greater than 2% when using specific lots of v-lyte dilution check solution; and2. integrated multisensor (imt) urine sodium drift - elevated urine sodium quality control (qc) exceeding acceptable qc ranges with the dimension vista imt system. a greater urine sodium drift with urine qc than urine patient samples has been observed. however, not all imt sensors exhibit the described urine sodium qc drift.
  • Action
    1) For repeated dilution check relative bias failures, Siemens is advising users to contact Customer Care Centre for further assistance. 2) For repeated elevated urine sodium QC drifts, users are advised to load a new Integrated Multisensor Technology (IMT) sensor in addition to coordinating a combination of the steps detailed in the recall letter to minimise or eliminate the drift of urine sodium QC and patient samples as well as to prevent premature sensor replacement and additional troubleshooting. Users are requested to review the letter with their Medical Director.

Device

V-Lyte Dilution Check & V-Lyte Integrated Multisensor Technology (IMT). An in vitro diagnostic me...
  • Model / Serial
    V-Lyte Dilution Check & V-Lyte Integrated Multisensor Technology (IMT). An in vitro diagnostic medical device (IVD)V-Lyte Dilution CheckCatalogue Number: K840Material Number (SMN): 10445203Lot Numbers: KC6D01, KC6F01 & KC6J01 V-Lyte Integrated Multisensor Technology (IMT)Catalogue Number: K800AMaterial Number (SMN): 10484429Lot Numbers: 6KD875, 6KD877, 6MD882, 7AD886 & 7BD890 (& future lots until issue resolution)ARTG Number: 181686
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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