{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "199838", "product_res_number": "Z-1573-2023", "event_date_initiated": "2023-03-27", "event_date_posted": "2023-05-10", "recall_status": "Open, Classified", "res_event_number": "92184", "product_code": "JQP", "product_description": "TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities.", "code_info": "UDI-DI : 03770027519010\nAll TDHisto/Cyto software versions", "firm_fei_number": "3003995437", "recalling_firm": "Technidata S.A.", "address_1": "387 Avenue Jean Kuntzmann", "city": "Montbonnot St Martin", "country": "France", "additional_info_contact": "SAME\n334 760 41300", "reason_for_recall": "In a specific use case, when printing labels for slides, some labels may display wrong information", "root_cause_description": "Software design", "action": "Techidata issued Medical Device Recall Urgent letter via email on 3/27/23. Letter states reason for recall, health risk and action to take:\nTo prevent any occurrence of the issue, you must not close the current session, or open another one, or perform the printing of another label batch, until the label printing is finished.\nNote: printing is finished when the Printing dialog box closes.\nsoftware modification was performed to prevent the risks mentioned above.\nWe kindly ask you to fill the reply form below and return it to us at your earliest convenience.", "product_quantity": "1 unit", "distribution_pattern": "US Nationwide distribution in the state of CA.", "openfda": { "k_number": [ "K823785", "K800282", "K844907", "K821807", "K760739", "K892060", "K802471", "K800724", "K792158", "K781081", "K823110", "K832760", "K801210", "K861412", "K801438", "K782052", "K792129", "K761063", "K802594", "K822778", "K833353", "K823679", "K802251", "K801131", "K851321", "K885292", "K864557", "K770671", "K790543", "K820427", "K983468", "K781217", "K801664", "K810968", "K861778", "K830296", "K923316", "K834490", "K801167", "K964460", "K822932", "K820721", "K853026", "K881194", "K812604", "K810631", "K831830", "K821531", "K822146", "K842401", "K843365", "K800241", "K800242", "K781173", "K790336", "K780881", "K834300", "K871853", "K854265", "K821058", "K770877", "K893838", "K840502", "K871339", "K801091", "K822860", "K113007", "K822381", "K861844", "K810063", "K831574", "K803312", "K832746", "K831838", "K953652", "K934111", "K850659", "K861779" ], "registration_number": [ "3003453957", "3002809144", "3000126629", "3015967359", "3037000637", "8020888", "3006677029", "3003902721", "9610816", "3002821232", "3035708936", "8020030", "3013922172", "3003600763", "3024512705", "3009404844", "3038419886", "2245451", "3043012240", "3015738702", "3006543086", "3016438761", "3004032053", "3005798890", "9616936", "3013298431", "3009542936", "1219145", "3014840402", "3016764932", "3015426626", "3008789114", "9615754", "3017086896", "3027496319", "9614673", "3002807715", "2243471", "3010258456", "3023268435", "3042228064", "3004838836", "3003995437", "1220649", "9610865", "3004973408", "3013896610", "2432235", "3003825930", "3010825766", "3010097171", "3003618481", "3004959793", "3005509212", "2936921", "3030714692", "1225673", "3010141591", "3040278125", "3003559191", "2531491", "3021394862", "3030413550", "1950204", "3013646951", "3011187792", "3002889627", "3015058854", "9710492", "3006371704", "3009711478", "3020978007", "9616530", "3007134734", "3005862821", "3043012074", "1061932", "3003795116", "3012118659", "1000113657", "9610126", "8043909", "3011393376", "2029302", "2954323", "1119779", "3012104009", "3002710220", "3015633428", "3009731198", "3031570369", "3009129531", "3005333358", "3015969360", "9615507", "3025376092", "3009288740", "3008514395", "3010900203", "3042989733", "3004145393", "2431530", "8030392", "3015347724", "3011121740", "2517506", "1058332", "3027486032", "3002637618", "3008802064", "3000148879", "3006755541", "3011194542", "3011806823", "8043723", "1810909", "3012436569" ], "fei_number": [ "3007019572", "3003453957", "3002809144", "3001573851", "3000126629", "3015967359", "3037000637", "3006677029", "3003902721", "3003559576", "3002821232", "3035708936", "3013922172", "3003600763", "3024512705", "3009404844", "3038419886", "2245451", "3043012240", "3015738702", "3006543086", "3010700165", "3016438761", "3004032053", "3000203293", "3005798890", "3013298431", "3009542936", "1219145", "3014840402", "3016764932", "3015426626", "3008789114", "3017086896", "3027496319", "3002807715", "3002829675", "2243471", "3010258456", "3023268435", "3042228064", "3006461677", "3004838836", "3003995437", "1220649", "3004973408", "3013896610", "2432235", "3003500908", "3003825930", "3010825766", "3010097171", "3001451449", "3003618481", "3004959793", "3005509212", "2936921", "3030714692", "3010141591", "3040278125", "3003559191", "1000306472", "3021394862", "3030413550", "1950204", "3003516723", "3013646951", "3011187792", "3002889627", "3015058854", "3006371704", "3009711478", "3020978007", "3007134734", "3005862821", "3002803444", "3043012074", "3003795116", "3012118659", "1000113657", "3011393376", "3002806559", "1119779", "3012104009", "3002710220", "3002807167", "3015633428", "3009731198", "3031570369", "3009129531", "3005333358", "3015969360", "1000307651", "3025376092", "3009288740", "3008514395", "3010900203", "3042989733", "3004145393", "2431530", "3002671736", "3015347724", "2517506", "3027486032", "3002637618", "3008802064", "3000148879", "3002808498", "3006755541", "3011194542", "3011806823", "3002806350", "3008237827", "3003116995", "1810909", "3012436569" ], "device_name": "Calculator/Data Processing Module, For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2100", "device_class": "1" } } ] }