BEUDAMED
    FDA Enforcement Class III Terminated

    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.

    Recall: Z-0728-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0728-2018
    Event ID
    79015
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Perkinelmer Life Sciences, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 7, 2018
    Initiation Date
    August 2, 2017
    Classification Date
    February 27, 2018
    Termination Date
    July 31, 2018
    Address
    549 Albany St, N/A, Boston, MA, 02118-2512, United States

    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.

    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.

    Code Info

    AJM4G01, AJL8001, AJI4G01, AJL8M01, CJM8M01, CJL8M01, CJL8001

    Distribution

    Nationwide

    Quantity

    7