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U.S. Department of Health and Human Services

Class 3 Device Recall JANUS Automated Workstation & JANUS G3 Automated Workstation

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  Class 3 Device Recall JANUS Automated Workstation & JANUS G3 Automated Workstation see related information
Date Initiated by Firm August 02, 2017
Create Date February 27, 2018
Recall Status1 Terminated 3 on July 31, 2018
Recall Number Z-0728-2018
Recall Event ID 79015
Product Classification Station, pipetting and diluting, for clinical use - Product Code JQW
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.
Code Information AJM4G01, AJL8001, AJI4G01, AJL8M01, CJM8M01, CJL8M01, CJL8001
Recalling Firm/
Manufacturer		 Perkinelmer Life Sciences, Inc.
549 Albany St
Boston MA 02118-2512
For Additional Information Contact Lisa Allen
800-762-4000
Manufacturer 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 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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