Retiro De Equipo (Recall) de 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    A software anomaly with tca software v4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the engen track.
  • Acción
    On 26 April 2017, Ortho Clinical Diagnostic issued a notice titled "Important Product Correction Notification" and a response form (Ref. CL2017-090) to their customers via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all potentially affected enGen customers to inform them of the issue and provide them instructions on how to monitor and correct the issue if it has occurred. Foreign affiliates were informed by email on 26 April 2017 of the issue. Potentially affected customers are those that have enGen Systems with: 1) TCA software V4.2 and configured with Rack Exit Module(s) and/or a Rack Entry & Exit (Combined) Module(s), but not configured with any ES Flex modules, and/or 2) TCA software V4.2 and a Stago analyzer with the Stago STA-R interface. **Required Actions- 1) When checking samples in the Check drawer, do the following based on your enGen System configuration: -For enGen Systems configured with Rack Entry & Exit (Combined) Module or Rack Exit Module without ES Flex, you may observe an increase in Sample IDs (SID) with General Error Duplicate SID in router messages in the Check Window. Remove the samples that are falsely identified as Duplicate SIDs from the Check drawer and reload the sample on the track for further processing if needed. NOTE: Refer to the Question and Answer section on page 3 for how to identify which samples are falsely identified as Duplicate SIDs. - For enGen Systems configured with a Stago analyzer, you may observe and increase in SIDs with "Sample not defined in router" messages for samples returning from the analyzer. Perform all post-analytical processing steps for associated samples, such as recapping, sorting and storing, off-track (manually). 2) Complete and return the attached Confirmation of Receipt form by May 9, 2017. Customers with questions may contact the Technical Solutions Center at 1-800-421-3311, 24 hours per day 7 days per week


  • Modelo / Serial
    Serial numbers: 5GV6W2J, 3RHC23J, 7KSC15J, 953252, CXL941J & JG7BFB5J Product Code 952019-EG, 952020-EG, 952055
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Domestically - GA, IL, MO, NC & NY; Internationally - Canada, England, France, Italy & Spain
  • Descripción del producto
    enGen Track System with TCAutomation Software Version 4.2
  • Manufacturer


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