Events

Retiro De Equipo (Recall) de Device Recall OraQuick HCV Visual Reference Panel

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 OraSure Technologies, 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
    73643
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1509-2016
  • Fecha de inicio del evento
    2016-01-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-02-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144648
  • 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
    Assay,enzyme linked immunosorbent,hepatitis c virus - Product Code MZO
  • Causa
    Orasure technologies, inc. discovered the package insert included with the oraquick hcv rapid antibody test visual reference panel may be incorrect due to a complaint received from one of their customers. the customer reported they received the ora quick ebola visual reference panel instead of an oraquick hcv visual reference panel.
  • Acción
    Letters, dated January 15, 2016, and correct HCV VRP insert were sent to all customers who received HCV VRP lot 6648737. The letter stated the reason for the recall; and, asked users to discard the Package Insert that was included with the product and replace it with the corrected one provided with the letter. Questions regarding the recall should be directed to OraSure Sales Representative or our Customer Care Department at 1-800-ORASURE.

Device

Device Recall OraQuick HCV Visual Reference Panel
  • Modelo / Serial
    Item Number 1001-0343, Lot # 6648737
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MI, MO, MT, NC, ND, NE, NH, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, and WI.
  • Descripción del producto
    OraQuick HCV Visual Reference Panel || Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.
  • Manufacturer
    OraSure Technologies, Inc.

Manufacturer

OraSure Technologies, Inc.
  • Dirección del fabricante
    OraSure Technologies, Inc., 1745 Eaton Ave, Bethlehem PA 18018-1769
  • Empresa matriz del fabricante (2017)
    OraSure Technologies, Inc.
  • Source
    USFDA