Events

Retiro De Equipo (Recall) de Device Recall Vidiera NsP Nucleic Sample Preparation

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
    48660
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0454-2009
  • Fecha de inicio del evento
    2007-08-30
  • Fecha de publicación del evento
    2008-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-01-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71828
  • 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
    Pipetting and diluting system for clinical use. - Product Code JQW
  • Causa
    Incorrect results: under certain circumstances, when transfer volume is not within the set range, the vidiera nsp software does not report sample exclusion and does not flag the excluded sample in the "run results" report. the software error associated with the excluded sample appears as "liquid was not successfully transferred to well#..........The sample will be excluded from further proce.
  • Acción
    The customer notifications were initiated by Beckman Coulter on September 11, 2007 when all affected accounts were contacted via telephone, followed by a Product Corrective Action (PCA) was mailed via US Postal Service to all affected customers. The PCA informed the customers of the issue and instructed them to: (1) Review the "run Summary" event log for your samples. (2) Review the attached instructions describing the steps for identifying the samples affected by this error. (3) Complete and return the enclosed response form within 10 days so that we may maintain our records. The letter informed the customers that Beckman Coulter would provide a software update within 60 days. The letter also asked their customers to share the PCA with their staff and provide a copy of the PCA to any customers that they may have forwarded the affected products to. For questions regarding the PCA, please contact firm at 714-961-3634.

Device

Device Recall Vidiera NsP Nucleic Sample Preparation
  • Modelo / Serial
    Part Numbers: A22421, Version 1.0.41
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution including states of PA, MI, UT, WA, IL, and CA.
  • Descripción del producto
    Vidiera NsP Nucleic Sample Preparation, Part Number: A22421, Version 1.0.41
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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