Z-0728-2018Class III

JANUS & JANUS G3 Automated Workstation is an automated programmable liquid handling instrument intended for...

Name: Z-0728-2018 JANUS & JANUS G3 Automated Workstation is an automated programmable liquid handling instrument intended for...
Creator: Perkinelmer Life Sciences, Inc.
Published: 2017-08-02
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2017-08-02 / Terminated / root cause: manufacturing process

FDA source

Perkinelmer Life Sciences, Inc. began a recall of JANUS & JANUS G3 Automated Workstation is an automated programmable liquid handling instrument intended for use in clinical settings to facilitate the... on 2017-08-02. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0728-2018
Classification: Class III
Status: Terminated
Initiated: 2017-08-02
Posted: 2018-02-27
Terminated: 2018-07-31
Recalling firm: Revvity Health Sciences, Inc.
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.
Product code: JQW Station, Pipetting And Diluting, For Clinical Use
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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
Quantity in commerce: 7
Distribution: Nationwide
Product codes and lots: AJM4G01, AJL8001, AJI4G01, AJL8M01, CJM8M01, CJL8M01, CJL8001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0728-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0728-2018	Class III	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27

Product code JQW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)