Events

Retiro De Equipo (Recall) de IMx Theophylline Reagent Pack In Vitro Test

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 Diagnostic International, Ltd..

¿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
    37957
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0958-2007
  • Fecha de inicio del evento
    2007-04-11
  • Fecha de publicación del evento
    2007-07-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52441
  • 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
    Theophylline Reagent - Product Code LER
  • Causa
    A decrease in mp values (calibration curve net polarization value) has been observed with this reagent lot at all calibrator levels and may produce the following results: calibration error code 148 (polarization too small), calibration error code 172 (calibration not stored or calibration not accepted) controls out of range (when using a stored calibration curve).
  • Acción
    An April 11, 2007, Product Recall Letter was sent to all customers who received the affected lot. All customers who received the affected lot will be contacted. The following communication types were used: Product Recall Letter & Customer Reply Form. Letters were sent to customers by Federal Express Priority mail. The Customers were instructed the following: To discontinue use of and destroy IMx Theophylline reagent lot 41610QI00. If they had forwarded the lots listed in the Product Recall letter to other laboratories, they were instructed to inform them of this Product Recall and provide a copy of this letter to them. They also we instructed to retain a copy of the communication for their records

Device

IMx Theophylline Reagent Pack In Vitro Test
  • Modelo / Serial
    Lot #41610Q100; Expiration date 04/25/2008
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide: CA, IL, MA, NY, OR, PA, VA, and WV and countries of Germany and Singapore
  • Descripción del producto
    IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test. || This reagent system is composed of one bottle of Theophylline Pretreatment Solution, one bottle of Theophylline Antiserum (Mouse Monoclonal) and one bottle of Theophylline Fluorescein Tracer.
  • Manufacturer
    Abbott Diagnostic International, Ltd.

Manufacturer

Abbott Diagnostic International, Ltd.
  • Dirección del fabricante
    Abbott Diagnostic International, Ltd., 30 Bo Cruce Davila, Barceloneta PR 00617-3009
  • Source
    USFDA