Events

Retiro De Equipo (Recall) de Bond ReadyToUse Primary Antibody Thyroglobulin (1D4)

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
    68079
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0179-2015
  • Fecha de inicio del evento
    2014-04-18
  • Fecha de publicación del evento
    2014-11-06
  • 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=126910
  • 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
    Bond ready to use primary antibody thyroglobulin does not function as intended up to the expiry date on the product labelling. this was detected through an on-going stability program. there is a link between the age of the product and staining intensity.
  • Acción
    Leica Biosystems sent a Medical Device Recall Notification letter dated April 18, 2014, to all affected customers. The letter included instructions for customers to: 1) assess any results previously obtained by using the recalled products; 2) identify and destroy any unused or partly used recalled products or confirm that the recalled products are no longer in stock; and, 3) complete and return the attached Medical Device Recall Notification Acknowledgement Form. Customers with questions were instructed to contact Leica Microsystems by e-mail at LMGRA@leica-microsystems.com. For questions regarding this recall call 847-405-5413.

Device

Bond ReadyToUse Primary Antibody Thyroglobulin (1D4)
  • Modelo / Serial
    Product Code: PA0025; Lot Numbers and Expiration Dates: 24963, Expires 17 DEC 2014; 24228, Expires 15 OCT 2014; 23882, Expires 10 SEP 2014; 23366, Expires 23 JUL 2014
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MT, MY, NC, NH, NJ, NY, OH, ON, OR, PA, TN, TX, UT, VA, WA, WI and the District of Columbia, Internationally to Belgium, Bulgaria, France, Italy, Pakistan, Philippines, Russia, Saudi Arabia, Spain, Turkey, and the United Kingdom.
  • Descripción del producto
    Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL. || This reagent is for in vitro diagnostic use. Thyroglobulin (1D4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of thyroglobulin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated Bond system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's 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