Retiro De Equipo (Recall) de Device Recall IMMULITE/IMMULITE 1000 Third Generation PSA

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Total,prostate specific antigen(noncomplexed&complexed;) for detection of prostate cancer - Product Code MTF
  • Causa
    Negative bias results with the immulite¿ /immulite¿ 1000 third generation psa (prostate-specific antigen) kit was confirmed for two lots (d0119 and d0120). the investigation by siemens has confirmed that patient samples exhibit an average negative bias of approximately -22% with a range of -16% to -27% for samples recovering from 0.08 to 16.2 ng/ml.
  • Acción
    Siemens issued an Urgent Medical Device Recall Notice letter dated December 21, 2016, to their U.S.A customers via Fed Ex and an Urgent Field Safety Notice letter dated December 2016, to customers outside the US (OUS). The notices instruct customers to discontinue use of and discard the affected kit lots listed in Table 1 of the customer communication. Customers are requested to review the UMDR and or the UFSN with their Medical Director. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Recall letter within 30 days. U.S.A customers are advised to fax the Effectiveness Check questionnaire to (312) 275-7795. Field service personnel will be sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. Customers with questions should contact their local Siemens technical support representative.


  • Modelo / Serial
    Lot Numbers: 1) D01196 - Expiration date 2016-12-31 2) D0120 - Expiration date 2017-03-31
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Denmark, Brazil, Croatia and Germany
  • Descripción del producto
    IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) || Product Usage: || For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.
  • Manufacturer


  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Empresa matriz del fabricante (2017)
  • Source