Events

Retiro De Equipo (Recall) de Device Recall CD99 (H0361.1) Mouse Monoclonal Antibody.

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 Cell Marque 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
    59436
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-3110-2011
  • Fecha de inicio del evento
    2011-07-12
  • Fecha de publicación del evento
    2011-08-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102783
  • 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
    Immunohistochemistry reagents and kits - Product Code NJT
  • Causa
    Incorrect label on product bottle, although labeling on outer box is correct.
  • Acción
    The firm, Cell Marque, notified customers by telephone on July 12, 2011. The customers were instructed to return the product. Cell Marque immediately issued replacement of the product. If you have any further question or require additional documentation, contact the VP of Regulatory and Quality Affairs at (916) 746-8900.

Device

Device Recall CD99 (H0361.1) Mouse Monoclonal Antibody.
  • Modelo / Serial
    Lot Number 1113202A, Exp date: 2014-04.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) include state of : CA and country of: Great Britain.
  • Descripción del producto
    Cell Marque antibody CD99 (H036-1.1) || Mouse Monoclonal Antibody. || Cel Marque, 6600 Sierra College Boulevard, Rocklin, Ca 95677 || The Cell Marque CD99 Mouse Monoclonal Antibody is intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in sections of formalin fixed, paraffin embedded tissue sections using manual or automated IHC test methods. Use of this antibody is indicated as an aid in diagnostic determination of human tumors within the context of the patient's clinical history and other diagnostic tests evaluated by a qualified pathologist of physician.
  • Manufacturer
    Cell Marque Corporation

Manufacturer

Cell Marque Corporation
  • Dirección del fabricante
    Cell Marque Corporation, 6600 Sierra College Blvd, Rocklin CA 95677
  • Empresa matriz del fabricante (2017)
    Sigma-Aldrich Co. Llc
  • Source
    USFDA