Events

Rappel de JANUS Automated Workstation & JANUS G3 Automated Workstation

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Perkinelmer Life Sciences, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    79015
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0728-2018
  • Date de mise en oeuvre de l'événement
    2017-08-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-07-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161156
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Station, pipetting and diluting, for clinical use - Product Code JQW
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    AJM4G01, AJL8001, AJI4G01, AJL8M01, CJM8M01, CJL8M01, CJL8001
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    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.
  • Adresse du fabricant
    Perkinelmer Life Sciences, Inc., 549 Albany St, Boston MA 02118-2512
  • Société-mère du fabricant (2017)
    Perkin Elmer Inc.
  • Source
    USFDA