Events

Retiro De Equipo (Recall) de Abbott Diagnostics ReagentPhenobarbital for ARCHITECT cSystems & AEROSET 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 Abbott Laboratories Inc..

¿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
    36821
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0454-2007
  • Fecha de publicación del evento
    2007-01-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49406
  • 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
    Phenobarbital Reagent - Product Code DLZ
  • Causa
    Erratic elevated results and or the inability to calibrate due to imprecision.
  • Acción
    Abbott sent out a product recall letter on 9/26, 2006, to all consignees that received lot numbers 39074HW00, 41008HW00 and 42063HW00. The letter states that the firm has identified a Phenobarbital performance issue that is demonstrated by erratic elevated results and/or the inability to calibrate due to imprecision. Until the cause of this issue is identified, they have discontinued shipment of Phenobarbital reagent. It will be necessary to identity an alternate means for Phenobarbital testing during this time. AXSYM and TDxITDxFLx Phenobarbital are available as alternate testing options (consignee may contact the local sales person or Customer Service). Consignees also advised if they forwarded any of the Clinical Chemistry Phenobarbital lots listed above to another laboratory to provide a copy of the letter to their customer. If there are questions, they are advised to call Customer Service (US consignee) or local sales person (foreign consignee). Letter advises if user currently using or have inventory of lot number 39074HW00, expiration 9/30/06, to run two levels of quality control (QC) every 6 hours and be alert to QC trends. For those using or have inventory of lot numbers 41008HW00 & 42063HW00, they are advised to discontinue use of these lots and destroy them following laboratory procedures. Abbott will provide reimbursement for the destroyed kits. A customer reply form is provided.

Device

Abbott Diagnostics ReagentPhenobarbital for ARCHITECT cSystems & AEROSET System
  • Modelo / Serial
    39074HW00 (exp. 9/30/06), 41008HW00 (exp. 10/31/06), 42063HW00 (exp. 12/31/06)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution ---- USA and countries of of Canada, Chile, Germany, Australia
  • Descripción del producto
    Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics Division
  • Manufacturer
    Abbott Laboratories Inc.

Manufacturer

Abbott Laboratories Inc.
  • Dirección del fabricante
    Abbott Laboratories Inc., 820 Mission St, South Pasadena CA 91030-3142
  • Source
    USFDA