Events

Retiro De Equipo (Recall) de Device Recall Estrogen Receptor AB11 (Clone ID5)

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 Lab Vision Corporation.

¿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
    67065
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0775-2014
  • Fecha de inicio del evento
    2013-12-06
  • Fecha de publicación del evento
    2014-01-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124646
  • 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
    Reagents,specific,analyte - Product Code MVU
  • Causa
    Reports that the product is not performing as expected. in house testing showed no staining on breast cancer tissues.
  • Acción
    Lab Vision Corporation part of Thermo Fisher Scientific sent an Urgent Medical Device Recall letter dated December 6, 2013, to all affected customers. Revised letters will be sent on January 8, 2014. Changes include that the reagent is an Analyte Specific Reagent (ASR) and not an in vitro diagnostic device in the US. They also clarify that a false positive was reported by a customer and a false negative was confirmed during in house testing. Letters also correct the expiry date from 12/2013 to 03/2015. Data sheet was also updated to eliminate information stating that the presence of ER in breast tumors indicates an increased likelihood of response to estrogen therapy and also that the positive control must be determined by the investigator. If you have any questions, please contact Technical Service at 1-800-522-7270, option 2, option 7.

Device

Device Recall Estrogen Receptor AB11 (Clone ID5)
  • Modelo / Serial
    PN/ MS-354-P0, LN 354P1206K; Expiration 03/2015.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) including the states of TX and MA and internationally to: Turkey.
  • Descripción del producto
    Estrogen Receptor AB-11 (Clone ID5) || Mouse Monoclonal Antibody || 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA || Thermo Fisher Scientific || Anatomical Pathology || Tudor Rd., Manor Park || Rancorn, Cheshire WA7 1TA UK || Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.
  • Manufacturer
    Lab Vision Corporation

Manufacturer

Lab Vision Corporation
  • Dirección del fabricante
    Lab Vision Corporation, 46117 Landing Pkwy, Fremont CA 94538-6407
  • Source
    USFDA