Events

Retiro De Equipo (Recall) de Device Recall Novocastra Liquid Mouse Monoclonal Antibody Calretinin

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
    73823
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1704-2016
  • Fecha de inicio del evento
    2016-03-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-11-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145056
  • 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 calretinin when used in combination with specific lots of antibody diluent will give reduced staining.
  • Acción
    A Medical Device Recall Notification letter was sent via e-mail on April 5, 2015 to the consignees describing the nature of the recall and action that needed to be taken. The firm requested that the consignees take the following actions: Only use Novocastra Liquid Mouse Monoclonal Antibody Calretinin with the lot numbers of diluent specified. There is no need for retrospective review of tissue staining if appropriate positive controls were properly used and interpreted during the immuno / in situ staining. Complete and return the attached acknowledgment. The firm requests that consignees contact their local Leica representative if they have any questions or concerns, or alternatively please contact the firm at the following e-mail address; LMGRA@leica-microsystems.com

Device

Device Recall Novocastra Liquid Mouse Monoclonal Antibody Calretinin
  • Modelo / Serial
    Lot numbers: 6025204, 6029060, 6029949, 6035923 and 6036060.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- U.S., to the following states: AK, CA, FL, GA, MN, MT, NJ, OH, TX and WA; and, the country of Canada.
  • Descripción del producto
    Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. || Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.
  • 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