Events

Recall of ADVIA Chemistry Systems - Urea Nitrogen (UN). 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-2018-RN-00303-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00303-1
  • 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 the urea nitrogen reagent kit lots 408143 and 418290 for use on advia 1800, 2400 and xpt chemistry systems are failing to perform as intended due to microbial contamination of a bulk reagent during the manufacturing process. this may demonstrate as an increased incidence of calibration failures. results cannot be generated by the system when calibration fails.If calibration passes, there is a potential for falsely elevated patient and quality control results.Internal testing has also shown that for the affected lots, results have the potential to be falsely increased by approximately 10 mg/dl (3.57 mmol/l) across the analytical range. quality controls may not always detect the elevated results.
  • Action
    Siemens is advising customers to discontinue use of and discard affected kit lots. A replacement for discarded units will be provided.

Device

ADVIA Chemistry Systems - Urea Nitrogen (UN). An in vitro diagnostic medical device (IVD)
  • Model / Serial
    ADVIA Chemistry Systems - Urea Nitrogen (UN). An in vitro diagnostic medical device (IVD) Catalogue Number: 03040257Lot Numbers: 408143, 418290Expiry (both lots): 28/06/2018ARTG Number: 176642Siemens Healthcare - Clinical chemistry substrate IVDs
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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