Events

Recall of ADVIA Chemistry System – Urea Nitrogen and Urea Nitrogen Concentrated Assays. 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-2015-RN-00739-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-08-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00739-1
  • 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 that urea nitrogen reagent kit lots listed and urea nitrogen concentrated reagent kit lots listed for use on advia 1200, 1650, 1800, 2400 and xpt chemistry systems demonstrate an increased incidence of calibration failures. results cannot be generated by the system when calibration fails. failed calibration may lead to a slight delay in results until a replacement or suitable material to perform the calibration verification is obtained. the risk to health is negligible.
  • Action
    Siemens is advising users that if they experience this issue, to request unaffected replacement product. Siemens is not recommending a review of previously generated results. This action has been closed-out on 07/09/2016.

Device

ADVIA Chemistry System – Urea Nitrogen and Urea Nitrogen Concentrated Assays. An in vitro diagnos...
  • Model / Serial
    ADVIA Chemistry System – Urea Nitrogen and Urea Nitrogen Concentrated Assays. An in vitro diagnostic medical device (IVD)Urea Nitrogen AssayCatalogue Number: 03040257Lot Numbers: 321973, 333872Expiry date: 2015-11Lot Number: 348126Expiry date: 2016-06Urea Nitrogen Concentrated AssayCatalogue Number: 06860558Lot Number: 321967 Expiry date: 2015-11Lot Number: 332365 Expiry date: 2016-03ARTG Number: 176642
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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