Retiro De Equipo (Recall) de Device Recall OC Light Manual iFOBT strips

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 Polymedco, 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
    64537
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1059-2013
  • Fecha de inicio del evento
    2013-02-12
  • Fecha de publicación del evento
    2013-04-04
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2016-02-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Reagent, occult blood - Product Code KHE
  • Causa
    The test strips in the affected product lots of the oc light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. there may be a possibility of obtaining false negative results when using the affected lots.
  • Acción
    Polymedco initiated phone calls to clients on 2/12/13. When the contact was made with the client, an URGENT DEVICE RECALL letter and Fax Form were sent by e-mail/fax. Mass mailing of the URGENT DEVICE RECALL letter dated February 12, 2013 and Fax Form was done by First Class USPS on 2/14/13-2/18/13. The recall affects the test strips only. For questions, please contact Polymedco Technical Support at 1-800-431-2123 ext 285.

Device

  • Modelo / Serial
    Kit Lot # P205877 - Kit Expiration Date 2/28/2013 - Test Strip Lot # 18004M;  Kit Lot # P210125 - Kit Expiration Date 3/31/2013 - Test Strip Lot # 19006M;  Kit Lot # P210204 - Kit Expiration Date 3/31/2013 - Test Strip Lot # 19006M;  Kit Lot # P212420 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M;  Kit Lot # P212421 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M;  Kit Lot # P210194 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X010M;  Kit Lot # P217043 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y012M;  Kit Lot # P234499 - Kit Expiration Date 11/30/2013 - Test Strip Lot # 25011M; Kit Lot # P234664 - Kit Expiration Date 11/30/2013 - Test Strip Lot # 26012M; Kit Lot # P238025 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26012M; Kit Lot # P238028 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26013M; Kit Lot # P243938 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26012M.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam.
  • Descripción del producto
    Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. || For the rapid, qualitative detection of human hemoglobin in feces.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Polymedco, Inc, 510 Furnace Dock Rd, Cortlandt Manor NY 10567-6220
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA