Events

Retiro De Equipo (Recall) de Device Recall ARCHITECT Ferritin Reagent

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 MPG.

¿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
    35612
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1204-06
  • Fecha de inicio del evento
    2006-06-06
  • Fecha de publicación del evento
    2006-07-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-01-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46468
  • 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
    Ferritin, Antigen, Antiserum, Control - Product Code DBF
  • Causa
    Some architect ferritin reagent lots may not be meeting the accuracy by correlation to axsym claims as they are listed in the package insert (slope of 1.0 +/- 0.2).
  • Acción
    Abbott international affiliates were e-mailed copies of the recall letter on 6/6/06 for translation where needed and dissemination to their accounts receiving the affected product. The end users were advised that a shift in patient and/or control results occurs when changing to reagent and calibrator lots manufactured using the new internal reference standard, and that the accuracy by correlation between Architect and AxSYM Ferritin reagent lots does not match those stated in the package insert. The accounts advised to set new targets for their controls or use the enclosed targets in Attachment A when they change to the assay materials manufactured using the new internal reference standards. The accounts were requested to keep a copy of the letter on file until the revised package insert is received.

Device

Device Recall ARCHITECT Ferritin Reagent
  • Modelo / Serial
    list numbers 6C11-20, 6C11-25 and 6C11-30; all lots
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Canada, Germany, Uruguay, Japan, Singapore, Hong Kong, South Korea, Australia and New Zealand
  • Descripción del producto
    ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100 tests) and 6C11-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064 USA
  • Manufacturer
    Abbott Laboratories MPG

Manufacturer

Abbott Laboratories MPG
  • Dirección del fabricante
    Abbott Laboratories MPG, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Source
    USFDA