Events

Recall of Dimension Troponin 1 (TNI) & Dimension Vista Digoxin (DIGXN), Estradiol (E2), Ferritin (FERR), Prolactin (PRL) & Thyroid Stimulating Hormone (TSH) 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-2017-RN-00458-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00458-1
  • 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 confirmed that the concentrations for biotin listed in the non-interfering substances section of the current dimension and dimension vista instructions for use (ifu) for dimension tni, dimension vista digxn, e2, ferr, prl, tsh have incorrect units, and incorrectly state the level at which biotin does not interfere. in the cases of tni, e2, ferr, prl, and tsh, there is significant interference at the levels incorrectly stated in the current ifu. dimension vista e2, a competitive assay, exhibits a positive bias while the other methods (sandwich assays) exhibit a negative bias. digxn si units for biotin are incorrect by a factor of 100 lower than the level at which biotin does not interfere, in the current ifu.The probability of misinterpretation of results is remote, and would be limited to when a patient taking biotin supplements in excess of the daily recommended allowance has a blood sample drawn before biotin is cleared to a level that does not interfere with testing.
  • Action
    Siemens is advising users of the correct biotin interference levels for the affected assays. This information should be reviewed with the laboratory Medical Director. In future, Siemens will be updating the IFU with the correct levels.

Device

Dimension Troponin 1 (TNI) & Dimension Vista Digoxin (DIGXN), Estradiol (E2), Ferritin (FERR), Pr...
  • Model / Serial
    Dimension Troponin 1 (TNI) & Dimension Vista Digoxin (DIGXN), Estradiol (E2), Ferritin (FERR), Prolactin (PRL) & Thyroid Stimulating Hormone (TSH) assays. An in vitro diagnostic medical device (IVD).Multiple Catalogue and Siemens Material Numbers (SMN)All Lots (including all future lots until the IFU is updated)ARTG Numbers: 182774, 182220, 180109, 181687
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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