Events

Retiro De Equipo (Recall) de Device Recall NeoMarkers Rabbit Monoclonal antiHuman Cyclin D1 Antibody (Clone SP4)

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 Lab Vision Corporation.

¿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
    56320
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2424-2010
  • Fecha de inicio del evento
    2010-03-05
  • Fecha de publicación del evento
    2010-09-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-03-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93227
  • 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
    Two lots may be contaminated with ki-67 antibody, which could cause abnormal staining patterns, and produce false positive results.
  • Acción
    Thermo Fisher Scientific issued an "Advisory Notice" letter dated March 5, 2010 to all domestic customers and international distributors. The letter described the product, problem and action to be taken. Customers were instructed to: 1) discard the affected lots, and 2) retest specimens using a replacement lot supplied by the firm, and 3) complete and return the Confirmation of Receipt Form via fax to 1-510-979-5489 International distributors were instructed to: 1) place the affected lots and replace with a replacement lot supplied by the firm, and 2) provide customers with copies of the customer letter, and 3) complete and return the Confirmation of Receipt Form via fax to 1-510-979-5489 For questions, contact Thermo Fisher Scientific at 1-800-828-1628 or 1-510-771-1595.

Device

Device Recall NeoMarkers Rabbit Monoclonal antiHuman Cyclin D1 Antibody (Clone SP4)
  • Modelo / Serial
    lots 9104S911A through 9104S911E and 9104S1001A, Catalog number RM-910, Expiration dates November 2011 and January 2012.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA, including the states of CA, SC, IL NY, WI, PA, MN, AL, WA, MA, and KS, and the coutnries of Austria, Australia, Denmark, Finland, France, Germany, Hong Kong, Italy, Japan, Malaysia, the Netherlands, Norway, Pakistan, Poland, Portugal, Russia, the UK, and Turkey.
  • Descripción del producto
    NeoMarkers Rabbit Monoclonal anti-Human Cyclin D1 Antibody (Clone SP4), immunochemistry Reagent and Kit, For In Vitro Diagnostic use, manufactured by Lab Vision Products, Fremont, CA, a subsidiary of ThermoFisher Scientific
  • Manufacturer
    Lab Vision Corporation

Manufacturer

Lab Vision Corporation
  • Dirección del fabricante
    Lab Vision Corporation, 47777 Warm Springs Blvd, Fremont CA 94539-7470
  • Source
    USFDA