The Recall Desk
LowFDA (Devices)·Z-0728-2018·Announced 2018-03-07

Perkinelmer Recalls Janus Automated Workstations Due to Circuit Board Defect

Perkinelmer is recalling seven Janus and Janus G3 automated workstations because defective circuit boards may cause horizontal motion errors and instrument downtime.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is limited to instrument downtime and operational errors, with no reported injuries or safety risks to patients.

Plain-English summary

Perkinelmer Life Sciences, Inc. is recalling seven units of the JANUS and JANUS G3 Automated Workstations. These instruments are used in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation workflows. The recall was initiated after internal testing revealed that the devices were failing production final acceptance testing due to a 'Horizontal Motion Error' message displayed on the system.

Investigation determined that two printed circuit boards (PCB) used in MDT models of the Janus and Janus G3 were manufactured with incorrect resistor values. This anomaly affects component part number 7101640 (PCB-Quad Motor Controller MDT) and part number 7101647 (PCB-Quad Motor Controller Gripper). The defect could result in the 'Horizontal Motion Error' being displayed, leading to instrument downtime.

The affected units were distributed nationwide. Users should be aware of the potential for the error message to display and should follow the guidance provided in the Janus Automated Workstation User Manual if the error occurs. For additional questions, users are advised to contact PerkinElmer Technical Support at (800) 762-4000.

The recalled product

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.
Affected units
7

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • AJM4G01
  • AJL8001
  • AJI4G01
  • AJL8M01
  • CJM8M01
  • CJL8M01
  • CJL8001

Distribution

Distributed nationwide across the United States.

Same manufacturer · Perkinelmer Life Sciences, Inc.

See all →