Events

Retiro De Equipo (Recall) de Liquid Specific Protein (LSP) Calibrator

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-2014-RN-01204-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-11-13
  • 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-2014-RN-01204-1
  • 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 has observed an increased frequency of max fit deviation flags using the lsp calibrator kit lot 303574 (vial lots 122it – 127it) to calibrate the alpha-1-antitrypsin (aat) assay. the max fit deviation flag impacts the level 2 calibrator (123it) for the advia chemistry systems alpha-1-antitrypsin (aat) assay. while there is a potential for delay in alpha-1-antitrypsin results due to calibration failures, the risk to health as a result of this issue is negligible.- the lsp calibrator ifu version that resided on the siemens document library from december 10, 2013 until april 7, 2014contained preliminary calibrator values that differed slightly from the final calibrator values for the following advia chemistry systems assays: aag, aat, aso_2, c3, c4, frt, hapt, iga_2, igg_2, igm_2, prealb, rf and trf. the differences between either the final or preliminary calibrator values would not affect the utility of these tests in clinical practice.
  • Acción
    Siemens is providing laboratories with the correct calibrator values.

Device

Liquid Specific Protein (LSP) Calibrator
  • Modelo / Serial
    Liquid Specific Protein (LSP) CalibratorCatalogue Number: 07711199Lot Number: 303574Expiry Date: Nov 2015An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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