Retiro De Equipo (Recall) de Device Recall ABX PENTRA Multical. ABX PENTRA N Control ABX PENTRA P Control

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
    67332
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1146-2014
  • Fecha de inicio del evento
    2014-01-20
  • Fecha de publicación del evento
    2014-03-05
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2014-12-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Calibrator, multi-analyte mixture - Product Code JIX
  • Causa
    Horiba medical is informing all abx pentra multical, n control, and p control customers running the creatinine rate blank method assay on the abx pentra 400 and pc200 that the target values for creatinine rate blank method have been updated. this issue is only applicable to creatinine rate blank method values reported on the abx pentra 400 and pc200 chemistry analyzers only. no other analyzers.
  • Acción
    HORIBA Medical initiated this recall by sending customers recall communication via FedEx week of January 20, 2014. The recall communication was a Field Safety Notice letter and Acknowledgement Form. The letter, dated 01/20/2014, titled "URGENT SAFETY NOTICE", informed customers of the recall by providing product description and codes, issue, impact, actiona/resolution, and contact information. The letter contained the following attachments: Field Safety Notice Acknowledgement Form and Updated Annexes with re-assigned values.

Device

  • Modelo / Serial
    Model Numbers:Multical - A11A01652, N Control - A11A01653, P Control - A11A01654.  Lot Numbers: MultiCal: 1204101 and 1304901, N Control: 1300801, P Control: 1300601.  Expiration Date (s): MultiCal: 1204101 Expires on 05/31/14, MultiCal: 1304901 Expires on 07/15/15, N Control: 1300801 Expires on 11/05/14, P Control: 1300601 Expires on 11/05/14.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    United States nationwide distribution.
  • Descripción del producto
    ABX PENTRA Multical. || ABX PENTRA N Control. || ABX PENTRA P Control. || The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two || measuring principals: absorbance and ion selective electrodes. || The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical || additives and materials of biological origin. The assigned values of the calibrator || components are given in the enclosed annex, ensuring optimal calibration of the || appropriate HORIBA ABX SAS methods on the ABX PENTRA Clinical Chemistry || Analyzer. This calibrator is provided in ten vials of 3 ml.
  • Manufacturer

Manufacturer

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