{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "161156", "product_res_number": "Z-0728-2018", "event_date_initiated": "2017-08-02", "event_date_created": "2018-02-27", "recall_status": "Terminated", "event_date_terminated": "2018-07-31", "res_event_number": "79015", "product_code": "JQW", "product_description": "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_info": "AJM4G01, AJL8001, AJI4G01, AJL8M01, CJM8M01, CJL8M01, CJL8001", "firm_fei_number": "1000513616", "recalling_firm": "Perkinelmer Life Sciences, Inc.", "address_1": "549 Albany St", "city": "Boston", "state": "MA", "postal_code": "02118-2512", "additional_info_contact": "Lisa Allen\n800-762-4000", "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.\nUntil PerkinElmer s corrective measures are completed, we request you;\n Be aware that there is potential for the Horizontal Motion Error message to display which could result in instrument down time.\n Follow guidance provided in the Janus Automated Workstation User Manual when the Horizontal Motion Error message displays.\n If you have additional questions, contact PerkinElmer Technical Support for further assistance (800) 762-4000.", "root_cause_description": "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", "product_quantity": "7", "distribution_pattern": "Nationwide", "openfda": { "k_number": [ "K800606", "K811001", "K883470", "K823364", "K770773", "K941498", "K770210", "K770355", "K821007", "K942655", "K842894", "K780912", "K822688", "K863624", "K922803", "K801271", "K893810", "K844798", "K962687", "K913664", "K851403", "K961694", "K883749", "K894272", "K922183", "K770307", "K781645", "K942290", "K780785", "K881195", "K822208", "K833959", "K831273", "K843606", "K812782", "K871687", "K781646", "K802520", "K893811", "K821034", "K781883", "K841043", "K842390", "K023955", "K936258", "K973335", "K864875", "K843607", "K770193", "K870406", "K862701", "K913809", "K915284", "K961896", "K912228", "K811696", "K896631", "K770208", "K801090", "K833666", "K894126", "K810509", "K896684", "K940390", "K832809", "K770013", "K801913", "K921005", "K863623", "K962859", "K843073", "K970616", "K813426", "K830319", "K834590", "K850800", "K890578", "K852285", "K843621", "K893775", "K893031", "K812983", "K923268", "K833505", "K803092", "K870544", "K861640", "K902592", "K912036", "K894271", "K800141", "K922327", "K790041", "K934124", "K944556", "K780882", "K952025", "K911712", "K863887", "K780789", "K812647", "K897158", "K801030", "K780208", "K840938", "K782130", "K970420", "K900775", "K821039", "K800075", "K953345", "K830157", "K913567", "K832205", "K900599", "K872363", "K860508", "K951753", "K941394", "K894710", "K915492", "K791324", "K933088", "K843779", "K761290", "K910140", "K801851", "K893400", "K873416", "K885340", "K832204", "K770772", "K980180", "K923879", "K831249", "K854406", "K894069", "K832202", "K861580", "K925547" ], "registration_number": [ "3013058950", "3027394506", "3013841562", "3009288740", "3016068451", "8043379", "3009746061", "3015797559", "3009034535", "3005248192", "2024800", "2016673", "3011240982", "3003559191", "2029275", "3003402518", "3010031137", "3009731198", "1217454", "2915274", "3004973408", "8030996", "3016837106", "3017955445", "8021864", "3005342322", "3004141078", "3010152370", "3004421347", "3009407607", "2029372", "9610126", "1618982", "3016611336", "3016436773", "3007082904", "3010594620", "3008256118", "3009963993", "3003703247", "3026753391", "1644474", "3009981484", "3009875001", "3007118747", "1119779", "3044758708", "8020790", "3005268307", "3007361513", "2243471", "2244900", "1832216", "2915796", "2024375", "3019512297", "3003825930", "1122376", "3010160459", "2916205", "3015728010", "3014325803", "3015376545", "3013894805", "3003268355", "1117676", "3010194621", "3003795116", "2531335", "3006421415", "3038193079" ], "fei_number": [ "3013058950", "3027394506", "3003572099", "3013841562", "3009288740", "3002806559", "3001236673", "3009746061", "3016068451", "3015797559", "3009034535", "3005248192", "2024800", "2016673", "3011240982", "3003559191", "1217454", "3003402518", "3010031137", "3009731198", "1000306617", "2915274", "3004973408", "3003413192", "3016837106", "3017955445", "1000306431", "3004141078", "3010152370", "3004421347", "3009407607", "1618982", "3016611336", "3016436773", "3007082904", "3010594620", "3008256118", "3009963993", "3003703247", "3026753391", "3009981484", "1000611339", "1000116989", "3009875001", "3007118747", "1119779", "3044758708", "3005268307", "3007361513", "2243471", "2244900", "1832216", "2915796", "2024375", "3019512297", "3001421318", "3003825930", "3010160459", "2916205", "3007529805", "3015728010", "3014325803", "3015376545", "3013894805", "3003268355", "1117676", "3010194621", "3003795116", "3005342322", "3006421415", "3038193079" ], "device_name": "Station, Pipetting And Diluting, For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2750", "device_class": "1" } } ] }