Events

Retiro De Equipo (Recall) de Device Recall CELLTRACKS AUTOPREP 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 Veridex, LLC.

¿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
    64304
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1949-2013
  • Fecha de inicio del evento
    2012-12-28
  • Fecha de publicación del evento
    2013-08-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115786
  • 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
    System, immunomagnetic, circulating cancer cell, enumeration - Product Code NQI
  • Causa
    Veridex, llc has received a report that a patient's demographics were incorrectly associated with another patient's identification (pid) number. the purpose of this notification is to inform you of the issue and provide instructions to help prevent an occurrence on your celltracks autoprep system and celltracks analyzer ii.
  • Acción
    Veridex sent an Important Product Correction Notification letter dated December 28, 2012, to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Confirmation of Receipt form. For questions contact Customer Technical Services at 1-800-421-3311.

Device

Device Recall CELLTRACKS AUTOPREP System
  • Modelo / Serial
    CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below). Product Code: CT4297B (9541).
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, China, India, Japan, Singapore, England, France, Germany, Italy and Spain.
  • Descripción del producto
    CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. || Product Usage: || The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks AutoPrep System software 2.4.1 release notes Pub. No. J40135EN issued 2012-03-26 page 2, the document states that a new feature unique to software 2.4.1 allows the used to modify a batch in a new way. The user has additional optional fields in the edit sample information dialog box that allows one to enter expanded sample and patient information. The user can also edit the patient management setting for selected samples if not all samples have the same designation.
  • Manufacturer
    Veridex, LLC

Manufacturer

Veridex, LLC
  • Dirección del fabricante
    Veridex, LLC, 1001 US Route 202, Raritan NJ 08869-0606
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA