Events

Retiro De Equipo (Recall) de Device Recall Assay for CA 27.29

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
    76766
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1748-2017
  • Fecha de inicio del evento
    2017-03-08
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154128
  • 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
    System, test, immunological, antigen, tumor - Product Code MOI
  • Causa
    Potential for the advia centaur syphilis assay to interfere with the br (ca 27.29) a assay on the advia centaur systems.
  • Acción
    Siemens Healthcare issued An Urgent Medical Device Correction (UMDC) to customers in the United States on March 08, 2017 to be delivered to customers on March 09, 2017and (UFSN) was sent for distribution to customers outside the United States on March 08, 2017. These notices inform customers of the potential and mitigation action to be taken for the ADVIA Centaur¿ Syphilis assay to interfere with the BR (CA 27.29) assay on the ADVIA Centaur Systems. This issue affects all current and future lots of ADVIA Centaur¿ Systems BR reagents until a solution is implemented. Fax-back forms included with letter used to confirm that the customers received the Urgent Medical Device Correction to the Customer Care Center at 312-275-7795. For questions regarding this recall call 508-668-5000. .

Device

Device Recall Assay for CA 27.29
  • Modelo / Serial
    All lot codes
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nationwide) Internationally to Australia, Brazil, Canada, Columbia, Cyprus, Japan, Spain
  • Descripción del producto
    Siemens ADVIA Centaur BR assay || Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) || BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, ADVIA Centaur¿ XP, and ADVIA Centaur¿ XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.
  • 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