{ "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": "130313", "product_res_number": "Z-0149-2015", "event_date_initiated": "2014-09-26", "event_date_posted": "2014-10-29", "recall_status": "Terminated", "event_date_terminated": "2017-07-10", "res_event_number": "69369", "product_code": "JQW", "product_description": "Freedom EVO-2 100 Base Unit, with Air LiHa Arms\n\nThe Freedom EVO is an open automation platform product for general laboratory use. It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes.", "code_info": "Part Number: 10641100, SN: 1407006311.", "firm_fei_number": "1037985", "recalling_firm": "Tecan US, Inc.", "address_1": "9401 Globe Center Drive", "address_2": "Suite 140", "city": "Morrisville", "state": "NC", "postal_code": "27560", "additional_info_contact": "Melody Humbles\n919-361-5200 Ext. 19519", "reason_for_recall": "Distortion (noise interference) of the liquid level capacitance can result in air aspiration instead of liquid aspiration. This might cause a false signal (air detection) with possible dispense errors resulting in erroneous results.", "root_cause_description": "Nonconforming Material/Component", "action": "Tecan sent an Urgent Field Corrective Action letter dated September 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\n\nTecan has instructed field engineers to replace the ZAAP Motion Board in the Freedom EVO instrument. Your instrument was identified as affected and a Tecan Service Representative will contact you to arrange replacement of the board.\n\nPlease make sure that your internal controls would detect any possible dispense errors that might affect your application when using the instrument before replacement of the board. Alternatively, stop using the instrument until the board is replaced.\n\nWe apologize for any inconvenience this issue may have caused,and are implementing corrective and preventive actions to prevent recurrence. If you have any further questions, please contact your local Tecan Helpdesk for assistance.\n\nFor further questions please call (919) 361-5200 ext. 19519", "product_quantity": "2 units", "distribution_pattern": "US Distribution to IL.", "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" } } ] }