Events

Retiro De Equipo (Recall) de Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

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 Sunquest Information Systems, 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
    62344
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2216-2012
  • Fecha de inicio del evento
    2011-04-28
  • Fecha de publicación del evento
    2012-08-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110298
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Causa
    In online entry (oex) there are two scenarios where a test result from one container may file to a test on another container. in order for this to occur: 1) site parameter sit 1,2,1,26 (3,217) [restrict resulting of tests to owner container (/n)]=y. 2) the tests are ordered on the same accession number and 3) the test codes are defined to have the same upload code as either replicate or.
  • Acción
    Sunquest sent an Urgent Product Safety Notice dated April 27, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For the 103 sites that still have this issue Sunquest distribute a new maintenance release. Customers were instructed to use LabAccess Results Workstation (LARS) instead of Online Entry when entering results for instrument method codes that are defined to use replicate tests that are typically ordered on the same accession. Customers were also instructed to share this notification with appropriate laboratory personnel. Customers were questions should call 520-570-2000. For questions regarding this recall call 520-570-2252.

Device

Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

Manufacturer

Sunquest Information Systems, Inc.
  • Dirección del fabricante
    Sunquest Information Systems, Inc., 250 S Williams Blvd, Tucson AZ 85711-4472
  • Empresa matriz del fabricante (2017)
    Roper Technologies Inc
  • Source
    USFDA