{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "150563", "product_res_number": "Z-0747-2017", "event_date_initiated": "2016-06-24", "event_date_created": "2016-12-12", "recall_status": "Terminated", "event_date_terminated": "2018-07-31", "res_event_number": "75508", "product_code": "JQW", "product_description": "Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized \nItem Number: 6000689.\nSupplied for use with JANUS Automated Workstations:\nProduct Number: AJS4001 AJM4001 AJI4001, AJL4001, AJS8001 , AJM8001, AJI8001, AJL8001, AJM4G01 , AJI4G01 , AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01 , AJL4M01, AJM8M01, AJI8M01, AJL8M01, AGS4NGS\nThe JANUS 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. The NGS Express is an automated, programmable liquid handling instrument suitable for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation workflows", "code_info": "Lot Numbers:15470394, 15471775, 1601067, 16071147", "firm_fei_number": "3009981484", "recalling_firm": "PerkinElmer, Inc", "address_1": "68 Elm St", "city": "Hopkinton", "state": "MA", "postal_code": "01748-1602", "additional_info_contact": "508-435-9500", "reason_for_recall": "Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspiration and dispensing", "root_cause_description": "Process control", "action": "PerkinElmer initiated recall on June 24, 2016 to the Product Manager and was delivered to the customer by email facilitated through PerkinElmer Sales Team.Customers were requested to take the following actions until PerkinElmer's corrective measures are completed:\nInspect customer inventory of the 6000689 25 Clear Filter Pipette Tip and identify if\nthe affected lots are present. Complete and return the attached Response Form with the required information. Destroy all quantities of tips from the affected lots.\nUpon receipt of the return Response Form, a shipment of replacement tips will be shipped.", "product_quantity": "595 trays (571,200 tips)", "distribution_pattern": "Worldwide Distribution - US including CA, MA, NY, IA, OR , PA, WA and Internationally to Belgium, Canada, Finland, France, Germany, Japan, Netherlands, Singapore, and UK", "openfda": { "k_number": [ "K861580", "K780882", "K833959", "K822688", "K912036", "K822208", "K800606", "K913567", "K863623", "K953345", "K830157", "K894271", "K925547", "K810509", "K781646", "K896631", "K812782", "K791324", "K843607", "K850800", "K770208", "K843779", "K811696", "K893810", "K851403", "K881195", "K780785", "K832204", "K893811", "K897158", "K894126", "K941498", "K844798", "K970616", "K861640", "K885340", "K800141", "K811001", "K842894", "K834590", "K832205", "K830319", "K770193", "K843073", "K801851", "K894272", "K896684", "K860508", "K913664", "K883749", "K900599", "K962687", "K871687", "K902592", "K813426", "K790041", "K854406", "K883470", "K980180", "K870406", "K952025", "K890578", "K770773", "K922803", "K781883", "K821007", "K936258", "K862701", "K770772", "K942655", "K894710", "K782130", "K894069", "K922327", "K800075", "K823364", "K821034", "K843621", "K893775", "K970420", "K915284", "K801090", "K911712", "K780912", "K915492", "K961896", "K893031", "K893400", "K833666", "K942290", "K900775", "K761290", "K801030", "K832809", "K780789", "K780208", "K812983", "K944556", "K961694", "K863624", "K831273", "K770355", "K864875", "K913809", "K923879", "K833505", "K870544", "K812647", "K940390", "K933088", "K962859", "K922183", "K840938", "K973335", "K781645", "K841043", "K770013", "K934124", "K821039", "K843606", "K801271", "K831249", "K801913", "K832202", "K873416", "K842390", "K770210", "K912228", "K770307", "K941394", "K802520", "K803092", "K951753", "K863887", "K921005", "K923268", "K023955", "K852285", "K872363", "K910140" ], "registration_number": [ "2243471", "3016837106", "3009034535", "3009288740", "3038193079", "2024800", "2915796", "3017955445", "1122376", "3010031137", "2029275", "3009746061", "3003825930", "3007082904", "3015797559", "8020790", "3010194621", "3004421347", "3005342322", "1644474", "3015376545", "3004141078", "9610126", "3013894805", "1217454", "2531335", "3006421415", "2016673", "3016436773", "1117676", "3004973408", "3009875001", "2916205", "3005248192", "3013058950", "3009407607", "3003402518", "2024375", "3044758708", "3014325803", "3011240982", "1618982", "1119779", "3010160459", "3016611336", "3003268355", "3015728010", "3009731198", "3027394506", "3013841562", "3007118747", "8021864", "2029372", "3010594620", "1832216", "3003559191", "3009963993", "3016068451", "3007361513", "3026753391", "3019512297", "8043379", "2244900", "2915274", "3005268307", "3003795116", "3010152370", "3009981484", "3003703247", "8030996", "3008256118" ], "fei_number": [ "2243471", "3016837106", "3009034535", "3001421318", "3009288740", "3038193079", "2024800", "2915796", "3017955445", "1000116989", "3010031137", "1000611339", "3009746061", "3003825930", "3007082904", "3015797559", "3010194621", "3004421347", "3002806559", "3005342322", "3015376545", "1000306431", "3004141078", "3013894805", "1217454", "3006421415", "2016673", "3001236673", "3016436773", "1117676", "3004973408", "3009875001", "2916205", "3005248192", "3013058950", "3009407607", "3003402518", "2024375", "3003572099", "3014325803", "3011240982", "1618982", "3044758708", "1119779", "3010160459", "3016611336", "3003268355", "3015728010", "3009731198", "3027394506", "3013841562", "3007118747", "3010594620", "3007529805", "1832216", "3003559191", "3009963993", "3016068451", "3007361513", "3026753391", "3019512297", "3003413192", "2244900", "2915274", "3005268307", "3003795116", "3010152370", "3009981484", "3003703247", "3008256118", "1000306617" ], "device_name": "Station, Pipetting And Diluting, For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2750", "device_class": "1" } } ] }