Recall Z-0728-2018 ยท JQW Station, Pipetting And Diluting, For Clinical Use
Perkinelmer Life Sciences, Inc.
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.
| Date | Aug 2, 2017 |
| Status | Terminated |
| 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 re |
| 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 | 7 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.