Events

Retiro De Equipo (Recall) de Device Recall Beckman Coulter Slidemaker Stainer

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 Beckman Coulter 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
    77778
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3101-2017
  • Fecha de inicio del evento
    2017-06-20
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157861
  • 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
    Counter, differential cell - Product Code GKZ
  • Causa
    The firm has identified that a fitting in some slidemaker stainer units may not completely seal after installation.
  • Acción
    Beckman Coulter sent an Urgent Medical Device Recall letter dated June 20, 2017. The notification advised consignees to immediately contact a Beckman Coulter representative if a leak is observed to schedule a service, to inspect reagent supply drawer for spills, and to follow best laboratory practices when using the device (including Personal Protective Equipment). Beckman Coulter indicates that the issue will be resolved with the replacement of the correct fitting on all impacted instruments. Labs were advised to notify all staff of the recall and to retain the notification. They were also instructed to forward the recall notice to all customers, if any product was further distributed, and to complete and return the Customer Response form within ten days of receiving the recall notification. Completed forms are to be sent back to the firm via email to Regulatory.Notifications@beckmancoulter.com. Regulatory Affairs Mail Code 31-B06. Questions can be directed to beckmancoulter.com or 800-526-7694. Consignees outside of the US are advised to contact their Beckman Coulter representative in the case that questions do arise.

Device

Device Recall Beckman Coulter Slidemaker Stainer
  • Modelo / Serial
    P/N A85371AA20; Catalog No. 775222
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, and WV., and to the countries of : Australia, Brazil, Canada, Chile, China, Czech Republic, Denmark, France, Greece, Hong Kong, India, Israel, Italy, Japan, Morocco, Portugal, South Korea, South Africa, Spain, Taiwan, Turkey, United Kingdom, Vietnam, and Switzerland.
  • Descripción del producto
    UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. || The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. || Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: Allows for the differentiation of white blood cells, facilitates the characterization of red blood cells and platelets, and aids in the identification of blood components and cellular abnormalities.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Dirección del fabricante
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA