Events

Retiro De Equipo (Recall) de IMMULITE 2000 and IMMULITE 2000 XPi - GI-MA (CA 19-9) Positive Bias

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-00131-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-02-18
  • 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-00131-1
  • 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 confirmed a positive bias with the bio-rad lyphochek tumor marker plus control and the bio-rad liquichek tumor marker control when used with immulite 2000/immulite 2000 xpi gi-ma (ca 19-9) assay kit lots 312 and 313.The bias in quality control values is the result of the introduction of a new lot of the bead coat antibody (murine monoclonal anti-ca 19-9 antibody) in kit lot 312. when comparing kit lot 312 with kit lot 311, siemens observed an average percent bias of 38% (ranging from 30% to 47%) for patient samples recovering from 29.6 to 44.4 u/ml and an average percent bias of 5% (ranging from 1% to 11%) for patient samples recovering from 540 to 660 u/ml.Future kit lots are expected to recover quality control and patient samples similar to kit lot 312.
  • Acción
    Siemens is advising that patients may need to be re-base lined with kit lot 312 or higher. A look back over previously generated results should be discussed with the treating physician.

Device

IMMULITE 2000 and IMMULITE 2000 XPi - GI-MA (CA 19-9) Positive Bias
  • Modelo / Serial
    IMMULITE 2000 and IMMULITE 2000 XPi - GI-MA (CA 19-9) Positive BiasCatalogue number: L2KGI2Siemens Material Number: 10380988Lot numbers: 312 and 313ARTG number: 180780
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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