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-00211-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00211-1
  • 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 has determined that affected lots of dimension vista blood urea nitrogen (bun) may exhibit inaccurate patient and/or qc results. the issue has been isolated to flex reagent cartridges manufactured from specific mold cavities. investigations indicate a loss of activity of the gldh reagent wells from specific mold/cavity identifiers. not all flexes are affected.·if calibration is performed using an unaffected well and patient results are subsequently run using an affected well, bun results may be falsely depressed by up to approximately 50% across the concentration range tested of 3.9 – 280 mmol/l (11–784 mg/dl). · if calibration is performed using an affected well, bun results may be falsely elevated by up to approximately 64% across the concentration range tested of 5.4 – 264 mmol/l (15–740 mg/dl)the risk to health as a result of this issue is remote and limited to falsely depressed bun results which may potentially result in the delay in the follow-up for kidney disease.
  • Action
    Siemens is advising users to inspect the affect products to determine if the cartridges have the affected Cavity Number, and discard any cartridges that have the specific lot and cavity number combinations. Cartridges which do not have the affected cavity numbers are unaffected and can continue to be used. Siemens is not recommending a review of previously generated results, however please discuss this letter with your Medical Director and consider the need for a look back at patient results generated with the affected cartridges.

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: 15215AE, 15243BB, 15264BA, 15299BB, 15300BA, 15320BB and 15341ACAffected Flex Cavity Number: B1, C3, C3, B3, B3, B1 and B4ARTG Number: 181689
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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