Events

Retiro De Equipo (Recall) de Device Recall ABX PENTRA ML

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 Horiba Instruments, Inc dba Horiba Medical.

¿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
    67528
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1173-2014
  • Fecha de inicio del evento
    2014-02-14
  • Fecha de publicación del evento
    2014-03-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125675
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Causa
    Horiba medical initiated this recall of all software versions of abx pentra ml (model a11a06152) due to a software bug with the potential of transmitting incorrect results to the laboratory information system.
  • Acción
    Horiba sent an "URGENT SAFETY NOTICE letter datedFebruary 13, 2014 via by mail to customers. The letter identified the affected product, issue, impact, actions to be taken. Customers were instructed to share this information with laboratory staff and retain this notification as part of their laboratory documentation. Customers were requested to complete and return the enclosed response form via one of the following methods: Fax: 949-453-0600 Email: jim.knowles@horiba.com Mail: HORIBA Medical Attention: Jim Knowles, Recall Coordinator 34 Bunsen Drive Irvine, CA 92618. For questions contact your local Horiba Medical representative.

Device

Device Recall ABX PENTRA ML
  • Modelo / Serial
    Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Shelf Life: N/A
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution
  • Descripción del producto
    Device Name: ABX PENTRA ML || Model/Part #(s): A11A01652 || Lot/Serial #(s): N/A || Software Version(s): All versions are subject to this correction. || Product Usage: || The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical

Manufacturer

Horiba Instruments, Inc dba Horiba Medical
  • Dirección del fabricante
    Horiba Instruments, Inc dba Horiba Medical, 34 Bunsen, Irvine CA 92618-4210
  • Empresa matriz del fabricante (2017)
    Horiba Ltd.
  • Source
    USFDA