Retiro De Equipo (Recall) de MicroVue CICC1q EIA

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 Diagnostic Hybrids, 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
  • 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
    Complement c1q, antigen, antiserum, control - Product Code DAK
  • Causa
    There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
  • Acción
    Customers were notified via letter on 4/4/17. Customers were asked to review their current inventory for the specified lot and complete and return the response form. If the product was further distributed, customers were instructed to provide them with the notification letter.


  • Modelo / Serial
    Lot 084007
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    The products were distributed to the following US states: NY, TX, CO, UT. The products were distributed to the following foreign countries: Switzerland.
  • Descripción del producto
    MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. || The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (¿g Eq/ml) can be determined by comparison to a standard curve.
  • Manufacturer


  • Dirección del fabricante
    Diagnostic Hybrids, Inc., 2005 E State St Ste 100, Athens OH 45701-2125
  • Empresa matriz del fabricante (2017)
  • Source