Events

Recall of JANUS Automated Workstation & JANUS G3 Automated Workstation

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Perkinelmer Life Sciences, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79015
  • Event Risk Class
    Class 3
  • Event Number
    Z-0728-2018
  • Event Initiated Date
    2017-08-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161156
  • Notes / Alerts
    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.
  • Extra notes in the data
    Station, pipetting and diluting, for clinical use - Product Code JQW
  • Reason
    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
  • Model / Serial
    AJM4G01, AJL8001, AJI4G01, AJL8M01, CJM8M01, CJL8M01, CJL8001
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    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.
  • Manufacturer Address
    Perkinelmer Life Sciences, Inc., 549 Albany St, Boston MA 02118-2512
  • Manufacturer Parent Company (2017)
    Perkin Elmer Inc.
  • Source
    USFDA