Events

Retiro De Equipo (Recall) de Device Recall EnVision FLEX, Mouse, High pH (Link)

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 Dako Denmark A/S.

¿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
    74608
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2330-2016
  • Fecha de inicio del evento
    2016-07-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148026
  • 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, general purpose - Product Code LDT
  • Causa
    The ph of target retrieval solution in the kit measures 4-5 instead of the correct ph of 9.1.
  • Acción
    A recall notification letter dated 7/6/16 was sent to customers to inform them that Dako is recalling EnVision FLEX+ kit because the pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1. The letter informs the customers that with a pH of 4-5 instead of pH 9 there could be weak staining, false negative or false positive non-specific staining depending on the antibody used. There is the possibility that this staining could lead to a false result. Customers are to discard the affected product, determine the impact as instructed, and confirmed that they have received replacement kits. Customers are instructed to complete the Device Recall Form and contact local sales representative for any questions regarding the recall notification.

Device

Device Recall EnVision FLEX, Mouse, High pH (Link)
  • Modelo / Serial
    K8002 Lot no: 10112879 K8004 Lot no: 10111463
  • Distribución
    Worldwide Distribution -- US, Canada, and Colombia.
  • Descripción del producto
    EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. || Intended for use in immunohistochemistry together with Autostainer Link Instruments.
  • Manufacturer
    Dako Denmark A/S

Manufacturer

Dako Denmark A/S
  • Dirección del fabricante
    Dako Denmark A/S, Produktionsvej 42, Glostrup Denmark
  • Empresa matriz del fabricante (2017)
    Agilent Technologies, Inc.
  • Source
    USFDA