Retiro De Equipo (Recall) de Device Recall Streptavidin Alkaline Phosphatase (Ready to Use)

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 Lab Vision Corporation.

¿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
    60967
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1089-2012
  • Fecha de inicio del evento
    2012-01-11
  • Fecha de publicación del evento
    2012-02-22
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-07-20
  • 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
    Immunohistochemistry reagents and kits - Product Code NJT
  • Causa
    Firm was notified by vendor that a component in kits was not meeting internal specifications. declination in product performance confirmed by thermo fisher.
  • Acción
    Lab Vision Corporation of Thermo Fisher Scientific sent a Product Recall Notification letters dated January 11, 2012 to all affected customers. The letter identified the affected products, reason for recall and necessary actions to be taken. Customers were instructed to examine inventory, discontinue use, destroy any remaining inventory, follow normal procedure to order an alternate lot of the affected products, retain a copy of this letter for their laboratory records, if the affected products were further distributed provide a copy of this letter to them and complete the attached Customer Recall Response Form and return within 5 days. For questions regarding this information, U.S. customers should call Technical Support at 510-771-1595. Customers outside the U.S. should contact their local area Customer Service.

Device

  • Modelo / Serial
    Catalog number: TS-060-AP; Lot Number: SAP101207, Exp 6/2012; Lot Number: SAP110216, Exp 2/2013.  Catalog number: TS-125-AP; Lot Number: SAP110106, Exp. 1/2013; Lot Number: SAP110405, Exp 10/2012.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) FL, IL, MA, TX and countries of Denmark, Turkey, Italy, Poland, Canada, Japan, Germany, Egypt and Greece.
  • Descripción del producto
    Streptavidin Alkaline Phosphatase (Ready to Use) || Manufactured by: Lab Vision Corporation || 46360 Fremont Blvd, Fremont, CA 94538 || Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Lab Vision Corporation, 46360 Fremont Blvd, Fremont CA 94538-6406
  • Source
    USFDA