Events

Retiro De Equipo (Recall) de Device Recall FastPack Total PSA Immunoassay

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 Qualigen 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
    66842
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0547-2014
  • Fecha de inicio del evento
    2013-11-08
  • Fecha de publicación del evento
    2013-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123724
  • 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
    Prostate-specific antigen (psa) for management of prostate cancers - Product Code LTJ
  • Causa
    Qualigen initiated this recall because the fastpack kit may cause lower than expected results due to a manufacturing defect.
  • Acción
    Qualigen, Inc., notified customers of the recall by calling customers via telephone (with a telephone script) on 11/08/2013. The telephone (script) included the reason for recall, product description with codes, instructions and contact information. The customers were instructed to examine your inventory and discontinue use of the kits immediately. Qualigen will send you replacement kits and provide you with a shipping label to return all of the defective kits including any that were partially used. Feel free to contact System Support at 760.579.6900 if you have any questions or require assistance with returning your kits.

Device

Device Recall FastPack Total PSA Immunoassay
  • Modelo / Serial
    Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
  • Descripción del producto
    FastPack Total PSA Immunoassay || Chemilunescence assay for the determination of Total PSA. || FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack Total PSA Immunoassay is designed for use with the FastPack System.
  • Manufacturer
    Qualigen Inc

Manufacturer

Qualigen Inc
  • Dirección del fabricante
    Qualigen Inc, 2042 Corte del Nogal, Carlsbad CA 92011-1438
  • Empresa matriz del fabricante (2017)
    Qualigen Inc
  • Source
    USFDA