Events

Retiro De Equipo (Recall) de Device Recall Spectrolyse PAI1

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 Sekisui Diagnostics Llc.

¿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
    63016
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2431-2012
  • Fecha de inicio del evento
    2012-08-28
  • Fecha de publicación del evento
    2012-09-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112279
  • 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
    Test, qualitative and quantitative factor deficiency - Product Code GGP
  • Causa
    Spectrolyse pai-1 activity assay producing lower than expected absorbance values with "0" standard. this will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions.
  • Acción
    The firm, Sekisui Diagnostics, LLC, sent an "URGENT PRODUCTS RECALL NOTICE" dated August 28, 2012 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to immediately stop using the product; to discard any remaining inventory and complete and return the Customer Acknowledgement Form by September 4, 2012 documenting the # of kits destroyed via FAX to Quality Assurance at 203-602-5553. The customers were also instructed to return the form even if they do not have the affected product currently in inventory. Sekisui will replace kits. If you have any questions contact, Customer Service Department at 800-637-3375, ext 10, 12, or 31, or email to recall coordinator at MKHAN@AMDIAG.COM.

Device

Device Recall Spectrolyse PAI1
  • Modelo / Serial
    Lot Numbers: 120425 and 120601
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: FL, IN, IL, and WA.
  • Descripción del producto
    Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. || Catalog Number: 101201 || For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.
  • Manufacturer
    Sekisui Diagnostics Llc

Manufacturer

Sekisui Diagnostics Llc
  • Dirección del fabricante
    Sekisui Diagnostics Llc, 500 West Avenue, Stamford CT 06902
  • Empresa matriz del fabricante (2017)
    Sekisui Chemical Co. Ltd.
  • Source
    USFDA