Events

Retiro De Equipo (Recall) de Free T3 Assays for use on the IMMULITE, IMMULITE 1000, IMMULITE 2000 and IMMULITE 2000 XPi analysers. 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-2013-RN-00915-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-08-30
  • 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-2013-RN-00915-1
  • 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
    The immulite/ immulite 1000/ immulite 2000 and immulite 2000 xpi free t3 assay kit lots listed with adjustor (lf3l/h) lot #135 are showing an elevated shift in patient values that exceed the upper limits of the normal reference range referenced in the immulite free t3 instructions for use (ifu). the elevated immulite free t3 results will not correlate with the results of other thyroid markers or free t3 results generated on other platforms.
  • Acción
    Siemens is requesting their customers to cease using the affected lots of reagent. Replacement with unaffected lots can be arranged to replace any stock. A look back of previously reported results is not recommended by Siemens as the assessment of thyroid function is generally based on multiple markers. However, the requirement for a look back should be determined at the discretion of the laboratory. Thia action has been closed-out on 29/01/2016.

Device

Free T3 Assays for use on the IMMULITE, IMMULITE 1000, IMMULITE 2000 and IMMULITE 2000 XPi analys...
  • Modelo / Serial
    Free T3 Assays for use on the IMMULITE, IMMULITE 1000, IMMULITE 2000 and IMMULITE 2000 XPi analysers. An in vitro diagnostic medical device (IVD).IMMULITE/IMMULITE 1000 FT3Catalog Number: LKF31Siemens Material Number: 10381626Lot Numbers: 353 & 354IMMULITE 2000/IMMULITE 2000 XPi FT3Catalog Numbers: L2KF32 & L2KF36Siemens Material Numbers: 10381675 & 10381682Lot Numbers: 737, 738, 739, 740, 741, 742 & 743ARTG number: 179720
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA