Retiro De Equipo (Recall) de Device Recall MEDITECH BiDirectional LAB Analyzer Interface

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 Medical Information Technology, 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
    65158
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1365-2013
  • Fecha de inicio del evento
    2013-05-07
  • Fecha de publicación del evento
    2013-05-22
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2014-10-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Medical device data system - Product Code OUG
  • Causa
    Incorrect transmission of laboratory results.
  • Acción
    Beginning on May 7, 2013, MEDITECH distributed a notification to MAGIC and Client Server customers who have the MEDITECH Bi-Directional Interactive Communication Analyzer Interface in use with Vitros 3600, 4600, or 5600 Analyzer in TEST and/or LIVE. This notification was made via remailed task updates that can be printed by the customer. Task updates sent via e-mail are immediately transmitted to the customer. This notification informs customers of the potential patient safety issue that could result in reporting inaccurate qualitative results. Customers will receive a corrective change, in which the previous test's results will no longer be associated with the test not performed. Until customers receive the corrective change, they are instructed to monitor all No Result values from their analyzer and confirm that the result in MEDITECH matches. For further questions please call 781-821-3000, ext. 5742.

Device

  • Modelo / Serial
    Magic Releases 5.41, 5.52. 5.53, 5.62, 5.63, 5.64 and Client Server Releases 5.64, 5.65, 6.05, 6.06, 6.07
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA, including Puerto Rico and the country of Canada.
  • Descripción del producto
    MEDITECH Bi-Directional interactive Communication Analyzer Interface; || Integrates with MEDITECH's Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Medical Information Technology, Inc., Meditech Circle, Westwood MA 02090
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA