Events

Retiro De Equipo (Recall) de Device Recall Siemens

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 Medical Solutions Diagnostics.

¿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
    67586
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1316-2014
  • Fecha de inicio del evento
    2014-02-03
  • Fecha de publicación del evento
    2014-04-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-06-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125774
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    There is a potential for incorrect results to be reported from processing of a sample tube.
  • Acción
    Siemens sent an Urgent Medical Device Correction letter dated February 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers was told how to correct the issue if it has occurred, and how to prevent the issue from occurring. The completed form should be faxed to (302) 631-7597. Any questions can be directed to Siemens Technical Support Representative. Siemens plans to implement a correction at a later time.

Device

Device Recall Siemens
  • Modelo / Serial
    IMMULITE 2000:  10380062, 10380061,10380079, 10380065, 10360210, 10283632  IMMULITE 2000XPi: P010053/S007;   10373214  VersaCell:   10380063, 10389945, 10380064, 10287115, 10793839
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide and Foreign Distribution.
  • Descripción del producto
    IMMULITE 2000; IMMULITE 2000XPi; VersaCell || The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000
  • Manufacturer
    Siemens Medical Solutions Diagnostics

Manufacturer

Siemens Medical Solutions Diagnostics
  • Dirección del fabricante
    Siemens Medical Solutions Diagnostics, 62 Flanders-Bartley Rd, Flanders NJ 07836-4715
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA