Events

Retiro De Equipo (Recall) de Device Recall MEDTOXscan

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 Medtox Diagnostics 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
    47501
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2202-2008
  • Fecha de inicio del evento
    2008-02-08
  • Fecha de publicación del evento
    2008-09-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69646
  • 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
    Amphetamine enzyme immunoassay - Product Code DKZ
  • Causa
    Reader was marketed without a 510(k).
  • Acción
    Consignees were notified by telephone starting 02/08/2008. They were being read the following script.: This is (company representative) calling regarding the MEDTOXscan Reader , Serial Number #######, that we sent to you on (date). Based on recent discussions with the FDA it has been determined that the reader should have had FDA clearance prior to MEDTOX marketing the reader. Since the MEDTOXscan Reader was marketed without 510(k) clearance it is considered mis-branded. MEDTOX is voluntarily recalling all readers until we receive this clearance. The PROFILE III ER devices sold for use with the readers are appropriately cleared by the FDA, and can be read visually, independent of the reader and therefore are not affected by the recall. Please discontinue using the reader immediately. We will send you shipping materials and instructions on how to return the reader to MEDTOX. You will receive these materials within the next 7 days and we request that you return the reader to MEDTOX within 5 days. Your assistance is appreciated and necessary. The Food and Drug Administration is aware of this recall.

Device

Device Recall MEDTOXscan

Manufacturer

Medtox Diagnostics Inc
  • Dirección del fabricante
    Medtox Diagnostics Inc, 1238 Anthony Rd, Burlington NC 27215-8936
  • Source
    USFDA