Events

Retiro De Equipo (Recall) de Device Recall 3mL 9NC Coagulation Sodium Citrate 3.2

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 Greiner Bio-One North America, 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
    62595
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2154-2012
  • Fecha de inicio del evento
    2012-07-02
  • Fecha de publicación del evento
    2012-08-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111118
  • 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
    Tubes, vacuum sample, with anticoagulant - Product Code GIM
  • Causa
    Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
  • Acción
    Distributors were notified by letter on 07/02/2012 and customers were sent a letter dated 07/05/2012. The letters identified the affected product and the reason for the recall. Distributors were asked to stop distributing the affected product and to complete the attached Product Disposition form. The form along with the affected product was to be returned to GBO. The firm will provide replacement stock or issue a credit once product return and receipt of the Product Disposition form has been confirmed. Customers were also asked to complete the Product Disposition Site Confirmation form and fax it back to Greiner Bio-One North America, Inc. at the number provided. The letter states that the firm will replace any affected product once the form is received. Questions should be directed to 800-515-8112.

Device

Device Recall 3mL 9NC Coagulation Sodium Citrate 3.2
  • Modelo / Serial
    Lot #B041206
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, || Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. || Intended Use: Venous blood collection tubes.
  • Manufacturer
    Greiner Bio-One North America, Inc.

Manufacturer

Greiner Bio-One North America, Inc.
  • Dirección del fabricante
    Greiner Bio-One North America, Inc., 4238 Capital Dr, Monroe NC 28110
  • Empresa matriz del fabricante (2017)
    Greiner Holding Ag
  • Source
    USFDA