Events

Retiro De Equipo (Recall) de Device Recall ABX PENTRA Urine Control L/H

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
    67133
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0924-2014
  • Fecha de inicio del evento
    2013-12-18
  • Fecha de publicación del evento
    2014-02-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124753
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • Causa
    Horiba medical is informing all abx pentra urine control l/h customers running the creatinine assay on abx pentra chemistry analyzers that the target range for creatinine has been updated. the abx pentra urine control l/h lot specific annexes have been updated to include revised acceptable target ranges for creatinine.No other analyte values are affected.
  • Acción
    HORIBA Medical sent an Urgent Safety Notice dated December 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to update their Quality Control procedures to include the new Creatinine Target Ranges for the ABX PENTRA Urine Control L/H Reference #: A11A01674 and Lot #s: 1207001, 1303601, and 1300701. Customers were instructed to complete and return the enclosed response form to verify their understanding of the Field Safety Notice. Customers with questions were instructed to contact their local HORIBA Medical representative. For questions regarding this recall call 949-453-0500.

Device

Device Recall ABX PENTRA Urine Control L/H
  • Modelo / Serial
    Model/Part #(s): A11A01674. Lot/Serial #(s): 1207001, 1303601, and 1300701. Shelf Life: Lot#s 1207001 & 1300701 Expire on: 06/30/2014. Lot# 1303601 Expires on: 09/30/2014.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Canada.
  • Descripción del producto
    ABX PENTRA Urine Control L/H. || The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control || consisting of liquid solutions prepared from human urine with chemical additives and || materials of biological origin added as required to obtain given component levels. The || assigned values of the control components are given in the labeling, ensuring control of || the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers. || Each control level is provided in one vial of 10 ml. || The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
  • 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