Events

Retiro De Equipo (Recall) de JANUS Automated Workstation & JANUS G3 Automated Workstation

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 Perkinelmer Life Sciences, 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
    79015
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0728-2018
  • Fecha de inicio del evento
    2017-08-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-07-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161156
  • 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
    Station, pipetting and diluting, for clinical use - Product Code JQW
  • Causa
    We have become aware through internal testing that janus and janus g3 automated workstations were failing production final acceptance testing due to a horizontal motion error message displayed on the system. further investigation concluded that two printed circuit boards (pcb) used in mdt models of janus and janus g3 were manufactured with the incorrect resistor values. this anomaly affects component part number 7101640 (pcb-quad motor controller mdt) and part number 7101647 (pcb-quad motor controller gripper). this anomaly could result in the horizontal motion error being displayed and result in instrument down time. until perkinelmer s corrective measures are completed, we request you; ¿ be aware that there is potential for the horizontal motion error message to display which could result in instrument down time. ¿ follow guidance provided in the janus automated workstation user manual when the horizontal motion error message displays. ¿ if you have additional questions, contact perkinelmer technical support for further assistance (800) 762-4000.
  • Acción
    On August 4 2017 an URGENT Medical Device Correction letter titled "Horizontal Motion Error" was issued to customers informing them of the error notice and to follow guidance provided in the Janus Automated Workstation User Manual when the Horizontal Motion Error message displays. Question or concerns can be directed to Technical Support at 800-762-4000

Device

JANUS Automated Workstation & JANUS G3 Automated Workstation
  • Modelo / Serial
    AJM4G01, AJL8001, AJI4G01, AJL8M01, CJM8M01, CJL8M01, CJL8001
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    JANUS & JANUS G3 Automated Workstation is an automated programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows.
  • Manufacturer
    Perkinelmer Life Sciences, Inc.

Manufacturer

Perkinelmer Life Sciences, Inc.
  • Dirección del fabricante
    Perkinelmer Life Sciences, Inc., 549 Albany St, Boston MA 02118-2512
  • Empresa matriz del fabricante (2017)
    Perkin Elmer Inc.
  • Source
    USFDA