Events

Retiro De Equipo (Recall) de Test Request Distributor (TRD) 1.3 and 1.4 of Dakos OMNIs System software module

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 Dako North America 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
    70898
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1548-2015
  • Fecha de inicio del evento
    2015-04-01
  • Fecha de publicación del evento
    2015-04-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135433
  • 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
    Slide stainer, automated - Product Code KPA
  • Causa
    If a user requests slides from the lis or tpid, then updates a request by changing the test, the trd software will reject the update. the lis and printed slide label will display the updated test with the requested change, but the omnis system will execute the initial test, not reflecting the change. the system will not warn the user that the test request was rejected.
  • Acción
    Dako sent a Voluntary Product Recall Notification letter starting the week of April 1, 2015 along with a acknowledgement attachment. The letter identified the affected product, problem and actions to be taken. The firm requests that customers inform those in their organization of the notification including organizations where the potentially affected instruments have been transferred. The firm requests that customers complete, sign, and return the acknowledgement form within one week after receiving the notification. For questions contact your Dako sales representative. On 04/29/15 the firm sent out an updated customer notification letter in order to provide additional clarification and instructions to customers in regards to the recall situation.

Device

Test Request Distributor (TRD) 1.3 and 1.4 of Dakos OMNIs System software module
  • Modelo / Serial
    N/A  Serial Number: 1311004352, 1308004862, 1307000537, 1405002266, 1410008844, 1307006995, 1311001075, 1402002186, 1401010308, 1402005995, 1306001697, 1311007317, 1410004066, 1404006200, 1410004067, 1405002263, 1404007225, 1410002144, 1311007321, 1404004226, 1401005960, 1305006010, 1401000919, 1405000371, 1401005963, 1403005465, 1304008205, 1401003711, 1401001048, 1310010425, 1401003715, 1311004354, 1311004355
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - U.S Nationwide in the states of IN and PA and the countries of: Spain, Belgium, France, Netherlands, Denmark, Finland, Sweden, Germany, UK, and Korea.
  • Descripción del producto
    Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro diagnostic use. || The TRD is intended to distribute patient case, appropriate parts information, track changes, and transform test requests from LIS or manual entries to connected Dako systems.
  • Manufacturer
    Dako North America Inc.

Manufacturer

Dako North America Inc.
  • Dirección del fabricante
    Dako North America Inc., 6392 Via Real, Carpinteria CA 93013-2921
  • Empresa matriz del fabricante (2017)
    Agilent Technologies, Inc.
  • Source
    USFDA