Events

Retiro De Equipo (Recall) de Device Recall Coulter PrepPlus

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
    77362
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2689-2017
  • Fecha de inicio del evento
    2017-05-22
  • 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=155841
  • 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
    Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis - Product Code PER
  • Causa
    When samples are prepared using the prepplus or prepplus 2 sample preparation systems and then run on a flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run.
  • Acción
    The recalling firm initiated their recall by letter disseminated via email on 05/22/2017. The letter requested the following actions be taken: 1. Insert an empty daughter tube in place of a patient sample as the first tube in the carousel that is programmed for the addition of Flow-Count Fluorospheres.  2. Refer to the COULTER PrepPlus Operators Guide / PrepPlus 2 Instructions for Use (IFU) for instructions on adding Flow-Count Fluorospheres to daughter tubes. 3. Review all results following the flow cytometer data review instructions referenced in the associated IFU. Beckman Coulter also requested the consignee share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If the consignee forwarded any of the affected product(s) listed above to another laboratory, They were asked to provide them a copy of the letter.

Device

Device Recall Coulter PrepPlus
  • Modelo / Serial
    All serial numbers currently in the field
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Coulter PrepPlus, Part Number 286600, || Product Usage: || The COULTER PrepPlus 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