Events

Recall of Dimension Vista Systems LOCI Thyroid Stimulating Hormone. 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 Ltd Diagnostics Division.

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-00357-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-04-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00357-1
  • 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 determined that dimension vista loci thyroid stimulating hormone (tsh) lot 14237aa may produce results with a negative bias ranging from -23% to -96% near the end of the well set due to inadequate reagent volume in a flex well. the occurrence of this issue is low. quality control will detect the issue if it is run near the end of an affected well set. the potential for clinical impact as a result of this issue is limited to a delay in hypothyroidism investigations. when this issue occurs, it is likely the negatively biased tsh values will not correlate reciprocally with free or total thyroid hormone values. in cases of monitoring tsh suppression for thyroid cancer, the potential for clinical misinterpretation of a patient’s response to thyroid hormone replacement therapy exists.
  • Action
    Siemens is instructing customers to discontinue and discard remaining inventory of the affected lot as a result of this issue. A look back at the previously generated results using the affected lot is recommended provided the sample is within the specified storage conditions and time, and where a TSH value within or below the reference interval did not reciprocally correlate with free or total thyroid hormone values.

Device

Dimension Vista Systems LOCI Thyroid Stimulating Hormone. An in vitro diagnostic medical device (...
  • Model / Serial
    Dimension Vista Systems LOCI Thyroid Stimulating Hormone. An in vitro diagnostic medical device (IVD)Assay: TSHCatalogue Number: K6412Siemens Material Number (SMN): 10445104Lot Number: 14237AAARTG number : 180109
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA