Events

Retiro De Equipo (Recall) de CELLDYN Emerald Diluent 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.

¿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
    56968
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1668-2011
  • Fecha de publicación del evento
    2011-03-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95077
  • 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
    The product bar code label, when scanned, indicates that the volume is 10 ml rather than the correct volume of 10,000 ml. analytical results are not impacted, although, there is a potential for delay in generating results.
  • Acción
    Product Recall notification letters were sent on 9/30/2010. The letter identified the affected product, an explanation of the problem, patient impact, and necessary actions. Consignees are to contact their local hematology customer support representative to arrange for replacement of the CELL-DYN Emerald Diluent Lot. Once the replacement lot has been received, customers should destroy the affected lot according to their laboratory procedures. A copy of the letter should be retained for their records and the Customer Reply Form should be completed and returned via fax or e-mail. US customers should contact Customer Support at 1-877-4ABBOTT, if they have questions.

Device

CELLDYN Emerald Diluent Reagent
  • Modelo / Serial
    Lot Number: 4350, Expiration Date: June 30, 2012
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including states of PA, NY, CA, NC, IL, TX, KS, UT, VA, FL, AR, TN, MN, NE, MI, and DE and the country of Germany.
  • Descripción del producto
    Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02, || Product is manufactured and distributed by || Abbott Diagnostics Division, Santa Clara. CA || Designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.
  • Manufacturer
    Abbott Laboratories

Manufacturer

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