Events

Retiro De Equipo (Recall) de Device Recall Novocastra Liquid Mouse Monoclonal Antibody Glutathione STransferase pi

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 Leica Microsystems, 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
    68065
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1698-2014
  • Fecha de inicio del evento
    2014-02-26
  • Fecha de publicación del evento
    2014-06-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126892
  • 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
    Novocastra liquid mouse monoclonal antibody glutathione s-transferase pi (product code: ncl-l-gstpi-438) does not function as intended up to the expiry date on the product labeling. this was detected through an ongoing stability program. there is a linkage between the age of the product and staining intensity.
  • Acción
    Leica Biosystems sent a Medical Device Recall Notification letter dated February 26, 2014 to all direct accounts. The letter advised that clinicians may want to review results obtained from the affected products. The letter also included instructions for customers to: 1) appropriately destroy any unused or partially used NCL-L-GSTpi-438 (lots 6018777, 6023260,6026297, 6026980) reagent or confirm that they are not in stock; 2) complete and return the attached Medical Device Recall Notification Acknowledgement Form to 847-236-3747; and, 3) contact the local Leica representative immediately if replacement is required. Customers with questions or concerns about this recall can contact Leica via e-mail at LMGRA@leica-microsystems.com. For questions regarding this recall call 847-405-5413.

Device

Device Recall Novocastra Liquid Mouse Monoclonal Antibody Glutathione STransferase pi
  • Modelo / Serial
    Product Code: NCL-L-GSTpi-438; Lot Numbers and Expiration Dates: 6018777, Expires 2014-05; 6023260, Expires 2014-12; 6026297, Expires 2015-05; 6026980, Expires 2015-06
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AZ, CA, FL, and NY.
  • Descripción del producto
    Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • Dirección del fabricante
    Leica Microsystems, Inc., 1700 Leider Ln, Buffalo Grove IL 60089-6622
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA