Events

Retiro De Equipo (Recall) de Device Recall Cell Marque CD7 (MRQ12);

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
    61055
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1176-2012
  • Fecha de inicio del evento
    2012-01-23
  • Fecha de publicación del evento
    2012-03-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107190
  • 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
    Letter received from supplier that material received in october 2009 was labeled as cd7, but was actually cd 2.
  • Acción
    Cell Marque sent a Field Notification letter dated January 23, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete and return the attached form indicating they have received the notification. Customers were also asked to destroy any existing inventory of the affected product. If the product was shipped to their customers, customers should confirm that they have contacted those customers. Customers were asked to complete, sign and date and return the attached Acknowledgement Form by faxing it to 1-916-746-8989 or by scanning it and emailing it to bdevos@cellmarque.com. For questions regarding this recall call 1-800-665-7284 or 1-916-746-8900. .

Device

Device Recall Cell Marque CD7 (MRQ12);
  • Modelo / Serial
    Catalog numbers: 107M-14 (0.1 ml concentrate); 107M-15 (0.5 ml concentrate); 107M-16 (1.0 ml concentrate); 107M-17 - (1.0 ml predilute) and 107M-18 (7.0 ml predilute). Product lot # 8109, Exp 2012-09.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Greece, Turkey, Italy, The Netherlands, Spain, Portugal, France, Israel, S. Korea, Pakistan, Morocco, Russia and Brazil.
  • Descripción del producto
    Cell Marque CD7 (MRQ-12); || Mouse Monoclonal Antibody, || Antibody is bottle in HDPE bottle with screw cap lid with container label. Then put in cardboard Box with outer box label. || Cell Marque, Rocklin, CA 95677, || intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in section of formalin fixed, paraffin embedded tissue section 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 or physician.
  • Manufacturer
    Cell Marque Corporation

Manufacturer

Cell Marque Corporation
  • Dirección del fabricante
    Cell Marque Corporation, 6600 Sierra College Blvd, Rocklin CA 95677-4306
  • Empresa matriz del fabricante (2017)
    Sigma-Aldrich Co. Llc
  • Source
    USFDA