Events

Retiro De Equipo (Recall) de Coulter PrepPlus 2

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
    59535
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0028-2012
  • Fecha de inicio del evento
    2010-08-12
  • Fecha de publicación del evento
    2011-10-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103035
  • 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
    Station, pipeting and diluting for clinical use - Product Code JQW
  • Causa
    The recall was initiated because beckman coulter has confirmed an issue with the coulter preplus 2. the reagent level sensing is impaired and will give no warning when a reagent vial is low or out of reagent. due to the size difference in the vertical mounts, the reagent rack is not aligned optimally for the probe to aspirate or level sense the antibody. this misalignment yields impaired reagen.
  • Acción
    Beckman Coulter initiated an URGENT: PRODUCT CORRECTIVE ACTION (PCA) letter dated August 24, 2010, with attached PCA Response Form to all affected customers who purchased the Coulter PrepPlus 2. The letter provided the customers with an explanation of the problem identified and an action to be taken. The customers were instructed to not use the PrepPlus2 until their Beckman Coulter representative corrects the problem. A review of all results generated from samples prepared from the system should be conducted. Any unexpected dim fluorescence and/or decreased number stained cells should be evaluated for re-analysis, including preparing a new sample. Customers were also instructed to complete and return the enclosed response form within 10 days. Customers with any questions regarding this PCA, were instructed to call Beckman Coulter Customer service at (800) 526-7694. Outside of USA, customers were instructed to contact their local Beckman Coulter Representative.

Device

Coulter PrepPlus 2
  • Modelo / Serial
    Serial Numbers: 1001008698, 1001008699, and 10018700.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution.
  • Descripción del producto
    Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. || Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
  • 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