Events

Retiro De Equipo (Recall) de Dimension Vista Systems LOCI Thyroid Stimulating Hormone. An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Ltd Diagnostics Division.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00357-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-04-23
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00357-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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 (...
  • Modelo / 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
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA