Retiro De Equipo (Recall) de Device Recall AtheNA MultiLyte MMV Test System AtheNA MultiLyte MMRV Test System A93111G

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 Zeus Scientific, 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 3
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización 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
    Enzyme linked immunoabsorbent assay, mumps virus - Product Code LJY
  • Causa
    Select lots of athena multi-lyte mmv test system have lost reactivity and may produce false positive results in seronegative patients who have not been previously affected with or vaccinated against mumps.
  • Acción
    The firm, Zeus Scientific, sent an "URGENT NOTICE; Voluntary Product Recall" letter dated March 8, 2012 their customers via Fed Ex. The letter described the product, problem and actions to be taken. The customers were instructed to remove and discard any remaining inventory of the listed product; if you are not the end-user and/or you have distributed these products to customers, notify them accordingly; and complete, sign and return the verification notice via fax to: 908-526-2058 or email a PDF to If you have any questions, call 908-526-3744 or 800-286-2111.


  • Modelo / Serial
    11120087 11120165  11110125 : (This is an amendment to add the additional lot 11110125 which was left off.. This amendment was made on 6/6/2012.)
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    AtheNA Multi-Lyte MMV Test System- A93111G || A microparticle-based immunoassay intended for the qualitative presumptive detection of IgG class antibody to the Mumps virus in human serum using the AtheNA Multi-Lyte Test System. The test system is intended to be used for determination of a previous infection with the Mumps virus.
  • Manufacturer


  • Dirección del fabricante
    Zeus Scientific, Inc., 200 Evans Way, Branchburg NJ 08876-3767
  • Empresa matriz del fabricante (2017)
  • Source