Events

Retiro De Equipo (Recall) de Device Recall Unicel DxH 800 Coulter Cellular Analysis System

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
    55699
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2338-2010
  • Fecha de inicio del evento
    2010-02-12
  • Fecha de publicación del evento
    2010-09-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-09-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91923
  • 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 recall was initiated after beckman coulter identified four (4) issues with the coulter lh 500 series system and the unicel dxh 800 coulter cellular analysis system: issue 1: there is a potential for misidentification to occur when the system is configured in languages other than english or chinese. the characters #,@,[,\,],`,{,|,}, or ~ are substituted or omitted in other languages. the issu.
  • Acción
    The customer recall notification was initiated when Product Corrrective Actions letters with attached Customer Response form were sent on the week of February 15, 2010 to all customers who purchased the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System. The letters will provided the customers with an explanation of the problem identified and a work around. Customers with questions regarding the Product Corrective Action were instructed to call 800-526-7694 in the United States or Canada, or contact your local Beckman Coulter Representative.

Device

Device Recall Unicel DxH 800 Coulter Cellular Analysis System
  • Modelo / Serial
    All serial numbers
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Throughout the United States and Canada
  • Descripción del producto
    Unicel DxH 800 Coulter Cellular Analysis || System
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Dirección del fabricante
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA