Reported Mar 7, 2018 · Terminated

JANUS & JANUS G3 Automated Workstation is an automated programmable liquid handling instrument intended for use in…

Perkinelmer Life Sciences, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Perkinelmer Life Sciences, Inc. · 549 Albany St · Boston, MA · 02118-2512

Is this the product you have?

  • 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.
Lot codes and dates
    • AJM4G01
    • AJL8001
    • AJI4G01
    • AJL8M01
    • CJM8M01
    • CJL8M01
    • CJL8001
Amount recalled
7

Where it was sold

  • Nationwide

Why it was recalled

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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 31, 2018 · Data as of Sep 19, 6:14 PM UTC

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