Events

Retiro De Equipo (Recall) de Device Recall COULTER PrepPlus 2, Part Number: 378600

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
    55166
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1759-2010
  • Fecha de inicio del evento
    2010-01-21
  • Fecha de publicación del evento
    2010-06-04
  • 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=90203
  • 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, pipetting and diluting, for clinical use - Product Code JQW
  • Causa
    The recall was initiated after beckman coulter confirmed reports of potential dilution of reagent vials loaded onto the preppies or prepplus 2 systems. affected systems have a syringe pump with part number a46748 (see illustrations below) which cause the probe to prematurely dispense isoflow prior to arriving at the wash station. this condition only occurs with worklist panels which include both.
  • Acción
    A Product Corrective Action (PCA) letter with attached PCA Response Form was sent on the week of January 25, 2010 to all customers who purchased the pipetting and diluting system: COULTER PrepPlus, or COULTER PrepPlus 2. The letter provides the customers with an explanation of the problem identified and an instruction on proper placing antibody reagent when using a worklist panel which involves both blood specimens and antibody reagents. Customers were also instructed to complete and return the PCA Response Form in addition to sharing the information contained in the PCA with their laboratory staff. If consignees had any questions they were told to contact their local Beckman Coulter Representative. Questions can be directed to the company's Customer Service office at (800) 526-7694.

Device

Device Recall COULTER PrepPlus 2, Part Number: 378600

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