Events

Retiro De Equipo (Recall) de Device Recall Leica

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
    70090
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1315-2015
  • Fecha de inicio del evento
    2014-12-16
  • Fecha de publicación del evento
    2015-03-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-09-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132240
  • 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
    The staining intensity decreases over the shelf life.
  • Acción
    Leica sent an Urgent Medical Device Recall Notification letters dated December 16, 2014 to all customers of record. The letters included instructions for customers to: 1) destory any usused and partially used recalled materials or confirm that the materials are no longer in stock; 2) complete and return the attached Field Safety Correction Notice Acknowledgement Form; 3) contact your local Leica representative immediately if a replacement is required; and, 4) pass this notice primarily to the end users where the product has been sold and to all those within your organisation who need to be aware of this manufacturing issue. Customers with questions can contact Leica Microsystems via e-mail at LMGRA@leica-microsystems.com.

Device

Device Recall Leica
  • Modelo / Serial
    Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: Lot 6022274, Expiry 2015-04; Lot 6024628, Expiry 2015-08; Lot 6030581, Expiry 2016-07
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of CA, CT, FL, IA, ID, IL, MT, NC, NY, TX, WA and in the countries of: Argentina, Australia, Bosnia and Herzegovina, Brazil, Canada, Chile, Denmark, El Salvador, France, Germany, Hungary, India, Italy, Japan, Netherlands, Nigeria, Portugal, Romania, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingdom.
  • Descripción del producto
    Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. || Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist.
  • 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