Events

Retiro De Equipo (Recall) de 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
    63829
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0645-2013
  • Fecha de inicio del evento
    2012-09-20
  • Fecha de publicación del evento
    2013-01-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114847
  • 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 is recalling abx pentra ml because they have confirmed an issue with the abx pentra ml data management and validation system. an incorrect patient result is transmitted to the laboratory information system. this result is from a previous run of the same patient that is stored in the ml database. this issue occurs in a very rare sequence of specific events. the affected software.
  • Acción
    .A recall letter dated 11/09/2012 was sent to all their customers who received the ABX PENTRA ML products. The letter informed the customers of the problem identified and the action to be taken. Customers are instructed to complete and return the enclose response form within 10 days. Customers with questions about the letter are instructed to contact their local HORIBA Medical representative. Recall Letter, as produced per FCD-0377, Field Safety Notice & Acknowledgement will be mailed via FedEx to the ten (10) customers noted on the list the week of November 12, 2012. Effectivity will be evaluated by receipt of the Field Safety Notice Acknowledgment Form. Follow-up communications with customers will be conducted, as needed.

Device

ABX Pentra ML

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