Data Foundry

Medical device recalls 2018

JANUS & JANUS G3 Automated Workstation is an automated programmable… — Class III medical device recall Z-0728-2018

Terminated recall by Perkinelmer Life Sciences, Inc., reported 2018-03-07, distributed nationwide. We have become aware through internal testing that JANUS and Janus G3 Automated Workstations were failing prod

Recall numberZ-0728-2018
Product typeMedical device
ClassificationClass III
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPerkinelmer Life Sciences, Inc., Boston, MA, United States
Recall initiated2017-08-02
Classified2018-02-27
Reported by FDA2018-03-07
Terminated2018-07-31
DistributedNationwide (US)
Quantity7

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 for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0728-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.