Events

Recall of Blood Urea Nitrogen (BUN) Flex Reagent Cartridge (used with Dimension Vista System). 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-00757-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00757-1
  • 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
    In february 2016, siemens healthcare diagnostics issued a letter, informing customers of well-to-well accuracy shifts for specific lots of dimension vista bun causing inaccurate patient and/or quality control results. preliminary investigation demonstrated loss of enzymatic activity of the gldh reagent wells made from a specific mold/cavity. siemens have since confirmed there is an additional cause of reduced gldh activity. · if calibration is performed using an unaffected well and samples are tested using an affected well, bun results may be falsely depressed by up to approximately 50% across the concentration range of 11 – 784 mg/dl. qc will detect the issue.· if calibration is performed using an affected well and samples are subsequently tested using an unaffected well, bun results may be falsely elevated by up to approximately 64% across the concentration range of 15 – 740 mg/dl. there may be in the delay in the follow-up for kidney disease.
  • Action
    Siemens is providing work around instructions to users to follow in order to detect the affected reagent well sets. The actions are strongly recommended to minimise the usage of affected reagents wells. Additionally, users are advised to discard any reagent cartridges with cavity number B4. Siemens is not recommending a review of previously generated results however, a review due to this issue is at the discretion of the laboratory director. This action has been closed-out on 20/01/2017.

Device

Blood Urea Nitrogen (BUN) Flex Reagent Cartridge (used with Dimension Vista System). An in vitro ...
  • Model / Serial
    Blood Urea Nitrogen (BUN) Flex Reagent Cartridge (used with Dimension Vista System). An in vitro diagnostic medical device (IVD)Catalogue Number: K1021Siemens Material Number: 10445159Lot Numbers: 16004AB, 16033AC, 16034AC, 16048AA, 16055AA, 16055AB, 16062AA, 16062AB and all future Vista BUN Flex reagent cartridges lots until further noticeARTG Number: 181689
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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