Events

Retiro De Equipo (Recall) de Device Recall Bond Polymer Refine Detection

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
    57333
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1065-2011
  • Fecha de inicio del evento
    2010-11-16
  • Fecha de publicación del evento
    2011-02-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95889
  • 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
    Users of the bond polymer refine detection system, ds9800, may experience instances of "weak staining" due to the dab part b component, which may give a false negative result.
  • Acción
    Leica Microsystems sent Medical Device Field Correction letters dated 11/16/10 to the affected users of the Bond Polymer Refine Detection System, DS9800 via first class mail on the same date, informing them that they may experience instances of "weak staining" due to the DAB Part B component in the affected lots, which may give a false negative result. The users were requested to test their DS9800 System prior to use to rule out that the DAB Part B components have been affected, using the enclosed testing protocol. If their system is affected, the users were instructed not to use it and contact Leica Technical Assistance Center for a replacement. The accounts were asked to complete the attached Acknowledgement Form, acknowledging the receipt and understanding of the letter, listing the lot numbers of the units at their facility and fax it back to Leica at 1-847-607-3147. Additional questions should be addressed to the firm's office of Regulatory Affairs and Quality Assurance.

Device

Device Recall Bond Polymer Refine Detection
  • Modelo / Serial
    Lot numbers 11279, 11297, 11315, 111604, 11693, and 11967.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA and Canada.
  • Descripción del producto
    Bond Polymer Refine Detection Kit; an in vitro diagnostic immunohistochemistry reagent kit; Catalog No. DS9800; || Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. || Intended for immunohistochemistry on paraffin-embedded tissue sections.
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • Dirección del fabricante
    Leica Microsystems, Inc., 2345 Waukegan Rd, Bannockburn IL 60015-1515
  • Source
    USFDA