Recall Z-0728-2018— Perkinelmer Life Sciences, Inc.

Class III FDA medical device recall by Perkinelmer Life Sciences, Inc., initiated 2017-08-02, terminated 2018-07-31. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..

Recalling firm

Perkinelmer Life Sciences, Inc.

Classification

Class III

Status

Terminated

Initiated

2017-08-02

Terminated

2018-07-31

Firm location

Boston, MA, United States

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