Events

Retiro De Equipo (Recall) de Device Recall enGen Laboratory Automation System

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 Ortho-Clinical Diagnostics.

¿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
    74354
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2143-2016
  • Fecha de inicio del evento
    2016-05-16
  • Fecha de publicación del evento
    2016-07-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147261
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    If the user selects the comment or interpretation option (in the engen .Gsb file), and the numerical results fall between negative and reactive, the im incorrectly displays the interpretive text as borderline and sends the incorrect text to the lis. the ifu states the interpretation term for these numerical result values is retest?.¿ the difference in terminology exists for us markets only.
  • Acción
    Ortho Clinical Diagnostics sent an "IMPORTANT PRODUCT CORRECTION NOTIFICATION" Customer Letter dated May 16, 2016, to all affected customers in the US with enGen Systems via FedEx or US Priority Mail (for Post Office Box addresses) or by e-mail to subscribers of ORTHO PLUS e-Communications to advise them of the issue and the required actions . Required Actions: 1. Use the numerical test results to assess actions to be taken for these assays, per the IFU. 2. Post this notification by your enGen System or with your user documentation. 3. Complete and return the Confirmation of Receipt form by 25 May 2016. with the Instructions for Use (IFU) directions). If you have any questions regarding this notification, please call the Ortho Technical Solutions Center at any time at 1-800-421-3311.

Device

Device Recall enGen Laboratory Automation System
  • Modelo / Serial
    Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; Serial Numbers/J Numbers: JIM341866, JIM341820, JIM341679, JIM341352, JIM343421, JIM341174, JIM336745, JIM340667, JIM338283,  JIM-341592, JIM336957, JIM341996, JIM342334, JIM343694, JIM336855,  JIM334236, JIM341415, JIM341392, JIM336481, JIM340934, JIM336167,  JIM342249, JIM338290, JIM341750, JIM341426, JIM334986, JIM334527,  JIM340024, JIM341021, JIM340658
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Dirección del fabricante
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Empresa matriz del fabricante (2017)
    The Carlyle Group LP
  • Source
    USFDA