Retiro De Equipo (Recall) de Device Recall HSV 1&2 IgM Enzyme Immunoassay Test Kit

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 Diamedix 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
  • 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, herpes simplex virus, non-specific - Product Code LGC
  • Causa
    On 01/16/20112 diamedix initiated a recall of is-hsv 1&2 igm test kit, catalog # 720-350, lot 60701, exp. june 30, 2012. the positive control for this lot is out of specification.
  • Acción
    Diamedix sent Recall notification letters dated January 16, 2012, to all affected customers by Certified Mail. Consignees were asked to review their inventory and then contact Diamedix to request replacement product. Customers were instructed to call 305-324-2314 with questions. For questions regarding this recall call 305-324-2560.


  • Modelo / Serial
    Lot # 60701
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution and Puerto Rico.
  • Descripción del producto
    Product is labeled in part: "***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay Test Kit***For the Detection of HSV 1&2 IgM antibodies***Catalog No: 720-350***Exp. Date:***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: ***For In Vitro Diagnostic Use***Caution, consult accompanying documents.***Manufacturer***Diamedix***A Subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127 USA-1-800-327-4565***Biohazard***" || The Is-HSV 1&2 IgM test kits are packaged in cardboard boxes with individual components secured within a foam insert. || The Diamedix Is-HSV 1&2 IgM Test Kit is intended for the qualitative detection of IgM antibodies to herpes simplex virus (HSV) type 1 and/or type 2 in human serum by indirect enzyme immunoassay. This test can aid in the diagnosis of a primary or reactived infection with HSV. The performance of this assay has not bee established for use in neonates, infants, or on cord blood, and immunocompromised patients.
  • Manufacturer


  • Dirección del fabricante
    Diamedix Corporation, 2140 N. Miami Avenue, Miami FL 33127
  • Source