Events

Retiro De Equipo (Recall) de Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, substrate, stop solution, wash buffer.). The individual vials are secured in the card board box. The test kit which is coated with the appropirate antigen, are placed in a foil pouch, which is also placed in the middle of the cardboard box.

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
    Recall
  • ID del evento
    29963
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0214-05
  • Fecha de inicio del evento
    2004-08-30
  • Fecha de publicación del evento
    2004-11-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-10-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34853
  • 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
    System, Test, Anticardiolipin Immunological - Product Code MID
  • Causa
    During packaging, lyme plates were packaged in this kit in error.
  • Acción
    Wampole Laboratories was contacted by Zeus on 8/30/3004. Wampole customers were then contacted by phone and letter to destroy all products on hand.

Device

Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plat...
  • Modelo / Serial
    Lot 04027128 exp 2005-10
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    25 units were sent directly from Zeus to their direct account Wampole Laboratories. The distributor contacted their customers to discard all affected kits. 8 units were shipped overseas to Israel. There were no ships to government facilities.
  • Descripción del producto
    Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, substrate, stop solution, wash buffer.). The individual vials are secured in the card board box. The test kit which is coated with the appropirate antigen, are placed in a foil pouch, which is also placed in the middle of the cardboard box.
  • Manufacturer
    Zeus Scientific Inc

Manufacturer

Zeus Scientific Inc
  • Dirección del fabricante
    Zeus Scientific Inc, 200 Evans Way, Somerville NJ 08876-3767
  • Source
    USFDA