Events

Retiro De Equipo (Recall) de Device Recall FP1000 Cell Preparation 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
    38369
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0002-2008
  • Fecha de inicio del evento
    2007-02-22
  • Fecha de publicación del evento
    2007-10-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53495
  • 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
    flow cytometer cell preparation - Product Code LXG
  • Causa
    Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented.
  • Acción
    A Product Corrective Action (PCA) letter was mailed on Feb 22, 2007, to all FP1000 customers to inform them of an issue associated with the FP1000 Cell Preparation System. Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented. Under these conditions the FP1000 will under-dispense specimen volume leading to lower than expected absolute counts. Specimen tubes that are recapped or underfilled must therefore be vented prior to running on the FP1000. If the initial state of the specimen tube is unknown, then it must be vented to ensure accurate results prior to running on the FP1000. Additional instructions are provided. A Fax Back Response Form was also provided.

Device

Device Recall FP1000 Cell Preparation System
  • Modelo / Serial
    Part Number 624922. Software versions 1.1 & 1.2
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide (MA, IN, IL, UT, RI, NJ), and Canada.
  • Descripción del producto
    FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Dirección del fabricante
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA