Recall Z-0728-2018
Perkinelmer Life Sciences, Inc. · initiated August 2, 2017
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: AJM4G01, AJL8001, AJI4G01, AJL8M01, CJM8M01, CJL8M01, CJL8001
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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
Details
- Recall number
- Z-0728-2018
- Initiated
- August 2, 2017
- Terminated
- July 31, 2018
- Product code
- JQW – Station, Pipetting And Diluting, For Clinical Use
- Quantity
- 7
- Distribution
- Nationwide
- Recalling firm
- Perkinelmer Life Sciences, Inc., Boston, MA