Events

Retiro De Equipo (Recall) de Device Recall MESOMARK

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 Fujirebio 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
    56427
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1606-2011
  • Fecha de inicio del evento
    2010-07-29
  • Fecha de publicación del evento
    2011-03-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93728
  • 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
    Cancer monitoring test system, soluble mesothelinrelated peptides, epithelioid/biphasic mesothelioma - Product Code OAW
  • Causa
    Presence of material attached to the bottom of some wells in places visible to the naked eye, which caused an overestimation of the sample.
  • Acción
    Notification dated 7/7/10 was sent to the customer via e-mail and FedEx Priority Overnight. FUJIREBIO Diagnostics, Inc. sent an URGENT PRODUCT CORRECTION NOTIIFICATION letter dated July 7, 2010, to all affected customers via e-mail and FedEx Priority Overnight. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue using MESOMARK kit. Lot 57K04510 and discard any remaining inventory. Complete and return the attached Confirmation of Receipt form upon receipt of this notification, no later than July 30, 2010. Notify your ordering physician or health care provider as appropriate. For questions regarding this recall call 877-861-7246 or 610-240-3800.

Device

Device Recall MESOMARK
  • Modelo / Serial
    Lot: 57K04510, Item # 801-905, Expiration Date: December 14, 2010 and Lot: 57K04409, Item# 801-905, Expiration Date: June 15, 2010
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    HDE
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including UT
  • Descripción del producto
    MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed with mesothelioma. Each kit contains 96 tests. || MESOMARK is an enzyme linked immunosorbent assay (ELISA) for the quantitative measurement of Soluble mesothelin Related Peptides (SMRP) in human serum. Measurement of SMRP may aid in the monitoring of patients diagnosed with epithelioid or biphasic mesothelioma. MESOMARK values must be interpreted in conjunction with all other available clinical and laboratory data.
  • Manufacturer
    Fujirebio Diagnostics, Inc.

Manufacturer

Fujirebio Diagnostics, Inc.
  • Dirección del fabricante
    Fujirebio Diagnostics, Inc., 201 Great Valley Pkwy, Malvern PA 19355-1308
  • Empresa matriz del fabricante (2017)
    Miraca Holdings, Inc.
  • Source
    USFDA