{ "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": "26603", "product_res_number": "Z-0869-03", "event_date_initiated": "2003-02-27", "event_date_posted": "2003-05-29", "recall_status": "Terminated", "event_date_terminated": "2006-04-06", "res_event_number": "25850", "product_code": "JQW", "k_numbers": [ "K953345" ], "product_description": "Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower.", "code_info": "Genesis 100, 150 &200, Tecan PosID2 units with firmware version 2.5 or lower", "firm_fei_number": "1037985", "recalling_firm": "Tecan U S Inc", "address_1": "4022 Stirrup Creek Rd,Ste310 4022 Stirrup Creek Rd Ste310", "city": "Durham", "state": "NC", "postal_code": "27709", "additional_info_contact": "Ron Wheeler\n919-361-5200 Ext. 509", "reason_for_recall": "Firmware defect. Under certain conditions a strip rack is no longer in the initial position after a motor overload of the barcode scanner PosID2.", "root_cause_description": "Other", "action": "Tecan US notified consignees by registered letter on/about 3/13/2003. International accounts were notified via e-mail 3/13/2003 by Tecan Switzerland. Consignees were advised to contact the firm''s Technical Support line to coordinate the PosID firmware upgrade.", "product_quantity": "327 instruments require firmware upgrade.", "distribution_pattern": "Instruments requiring upgrade were distributed to various clinical laboratories and blood banks Nationwide and World wide .", "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" } } ] }