BEUDAMED
    FDA Recall 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 · Initiated August 2, 2017

    Recall

    Recall Number
    Z-0728-2018
    Event Number
    79015
    Firm
    Perkinelmer Life Sciences, Inc.
    FEI Number
    1000513616
    Product Code
    JQW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 2, 2017
    Terminated
    July 31, 2018
    Address
    549 Albany St, Boston, MA, 02118-2512

    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.

    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

    Distribution

    Nationwide

    Quantity

    7