Events

Retiro De Equipo (Recall) de Siemens ADVIA Centaur Systems HBc Total (HBcT)

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Siemens Healthcare Diagnostics, Inc.

¿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
    69292
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0103-2015
  • Fecha de inicio del evento
    2014-09-15
  • Fecha de publicación del evento
    2014-10-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130184
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Test, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
  • Causa
    Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.
  • Acción
    Siemens Healthcare issued An Urgent Medical Device Recall (UMDR) sent to all affected Siemens Healthcare Diagnostics customers in the United States on September 15, 2014. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on September 15, 2014. These notices inform the customer of the imprecision and positive bias and a potential increase in initial reactive results associated with ADVIA Centaur Systems HBc Total Lot 100064. Customers were instructed to discontinue use of the affected lots and dispose of the product according to local regulations or procedures. The notices should be reviewed with the facility's laboratory or medical director. Each customer will be required to return a completed confirmation fax-back to Siemens.

Device

Siemens ADVIA Centaur Systems HBc Total (HBcT)
  • Modelo / Serial
    Lot Number:  36217064, 36281064, 36449064, 37406064, 38177064  Exp.Date:February 10, 2015
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Austria Bahrain Belgium Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iraq Ireland Italy Jordan Latvia Lebanon Lithuania Luxembourg Netherlands Norway Poland Portugal Romania Slovakia Spain Sweden Switzerland Turkey Unit.Arab Emir and Yemen.
  • Descripción del producto
    ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. || Catalog Number: 07566733 || Siemens Material Number: 10309508 || The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDT A, or lithium or sodium heparinized) using the ADVIA Centaur CP system.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc

Manufacturer

Siemens Healthcare Diagnostics, Inc
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA