Events

Retiro De Equipo (Recall) de Device Recall LIFECODES PF4 Enhanced assay

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 Genetic Testing Institute,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
    64501
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1022-2013
  • Fecha de inicio del evento
    2013-02-04
  • Fecha de publicación del evento
    2013-03-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116359
  • 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
    Platelet factor 4 radioimmunoassay - Product Code LCO
  • Causa
    Lifecodes pf4 enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit positive control and patient samples. the variation in reactivity can lead to invalid assays. if an invalid assay is obtained, those results should not be reported and the test should be re-run. an invalid assay would not result in significant harm to a pati.
  • Acción
    Hologic/Gen-Probe sent an Urgent Medical Device Recall letter dated February 4, 2013, via FedEx overnight deliver yto all affected customers. The letter identified affected product, stated the issue, and asked that product from the affected lot stop being used. Reported results for all samples tested using the affected lot should be reviewed. The referring physician should be notified that any negative patient result may be erroneous. Remaining inventory should be returned to Gen-Probe. A response form was also asked to be returned. For questions customers were instructed to contact Technical Support at 262-754-1000 or waukeshatechsupport@gen-probe.com. For questions regarding this recall call 262-754-1026.

Device

Device Recall LIFECODES PF4 Enhanced assay
  • Modelo / Serial
    Kit Lot Number 3000389
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.
  • Descripción del producto
    Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 || GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
  • Manufacturer
    Genetic Testing Institute,inc

Manufacturer

Genetic Testing Institute,inc
  • Dirección del fabricante
    Genetic Testing Institute,inc, 20925 Crossroads Cir Ste 200, Waukesha WI 53186-4054
  • Source
    USFDA