Events

Retiro De Equipo (Recall) de Device Recall Hemoglobin Reagent Syringe Used on the CELLDYN Sapphire Automated Hematology Analyzer

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.

¿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
    46368
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1165-2008
  • Fecha de inicio del evento
    2008-01-15
  • Fecha de publicación del evento
    2008-04-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-12-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67306
  • 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
    Differential Cell Counter - Product Code GKZ
  • Causa
    Count may be out of specification--hemoglobin background count may be out of specification (high) after installation of new cell-dyn sapphire hemoglobin reagent syringes with packaging dates between may 8, 2007 and november 29, 2007.
  • Acción
    On January 11, 2008, an Urgent Product Recall Letter and Customer Reply Form were sent to all currently active CELL-DYN Sapphire customers (end-users). The firm provided information for verification of replacement syringes and instructions if hemoglobin background is not within specification. A second Urgent Product Recall letter was sent on January 15, 2008. If this second Customer Reply Form is not faxed back to Abbott, customers will be contacted via an approved telephone protocol. For further information contact customer support at 1-877-4ABBOTT.

Device

Device Recall Hemoglobin Reagent Syringe Used on the CELLDYN Sapphire Automated Hematology Analyzer
  • Modelo / Serial
    All Hemoglobin Reagent Syringes, List No. 08H49-02, with packaging dates between May 8,2007 and November 29,2007. Each package is identified with product description "CDS HGB SRNG W/BU".
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA including states of AR, AZ, CA, GT, FL, GA, ID, IL, KY, LA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OM, OR, PA, SC, TN, TX, UT, VA, WI, and WV and countries of Canada, Mexico, Australia, Brazil, Canada, China, Chile, Columbia, Germany, Hong Kong, Japan, Mexico, Peru, Singapore, and South Korea.
  • Descripción del producto
    CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN Sapphire Automated Hematology Analyzer. Abbott Labs, Abbott Park, IL.
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Dirección del fabricante
    Abbott Laboratories, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • Source
    USFDA