{ "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": "115665", "product_res_number": "Z-0833-2013", "event_date_initiated": "2012-09-28", "event_date_posted": "2013-08-06", "recall_status": "Terminated", "event_date_terminated": "2016-02-24", "res_event_number": "64244", "product_code": "KPA", "product_description": "VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only\r\n\r\n\r\nProduct Usage:\r\nResearch Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ hybridization reagents.", "code_info": "Cat#750-600; PN 05342716001; Serial #'s: 310724, 310735, 311187, 312055, 310373, 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310903, 311022, 311025, 311088, 310660, 311274, 312146, 310027, 310909, 311922, 310134, 310041, 310232, 310613, 311497, 312062, 311575, 311740, 311970, 310538, 310644, 310873, 311822, 311536, 311980, 310188, 310574, 311383, 310925, 310958, 310960, 311030, 311019, 311179, 311180, 310121, 311087, 310877, 310449, 310450, 310487, 311515, 311427, 311516, 311452, 310219, 310239, 312203 All serial numbers in the market", "firm_fei_number": "1000125183", "recalling_firm": "Ventana Medical Systems Inc", "address_1": "1910 E Innovation Park Dr", "city": "Oro Valley", "state": "AZ", "postal_code": "85755-1962", "additional_info_contact": "Robert D. Brooks\n520-877-7191", "reason_for_recall": "Potiential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform. This type of overflow event can lead to migration of fluid across tubing and wiring within the instrument cabinet resulting in contact with electrical circuitry. This may create shorting conditions and u", "root_cause_description": "Device Design", "action": "The firm, Roche sent a \"Technical Bulletin\" and an letter dated October 3, 2012 to its customers. The letter and bulletin described the product, problem and actions to be taken. The customers were informed that Ventana is aggressively working on solutions to this issue. Until mitigations to the overflow condition are available for implementation; inform all personnel in your organization that work with the BenchMark ULTRA or DISCOVERY ULTRA instrument about the potential for fluid overflow to occur during decontamination cycles; follow the instructions provided in the letter to avoid the documented failure mode and follow the instructions provided in the technical bulletin.\r\n\r\nContact your local support center with any questions or concerns or call 520-877-7191.", "product_quantity": "1735 instruments", "distribution_pattern": "Worldwide distribution: USA (nationwide) and country of: Germany.", "openfda": { "k_number": [ "K780637", "K832994", "K881592", "K850157", "K770076", "K771699", "K872916", "K833295", "K884258", "K874887", "K880745", "K933996", "K821830", "K842077", "K811697", "K781598", "K850333", "K771559", "K853210", "K874897", "K780017" ], "device_name": "Slide Stainer, Automated", "medical_specialty_description": "Pathology", "regulation_number": "864.3800", "device_class": "1", "registration_number": [ "3010692993", "3038196622", "2432235", "3007648367", "3009547954", "1000391282", "1640981", "9610806", "3006198300", "9680927", "3013059683", "3043088937", "3043606682", "8010478", "3016621374", "1000303355", "3009596884", "3017439370", "1222780", "3020305854", "3010188766", "3002805583", "3009746061", "3003559191", "9615754", "3004859032", "3006606827", "1061932", "3015614371", "3009000266", "3008505743", "3004140393", "3013043616", "3009189893", "3005333358", "2083544", "3003601075", "3010889707", "3020704087", "9610099", "3033524192", "9613959", "3010685493", "3010461097", "3015167933", "8020030", "3009432145", "3010421384", "3009963993", "3009448641", "2030652", "3007035884", "3009711478", "2916205", "3005716001", "3014611360", "3043138885", "3006412379", "3027645317", "3003584784", "3019387954", "3008776165", "3016764932", "3003402518", "3006788232", "3003423869", "3014165737", "3003639866", "3031915160", "3038188821", "1063851", "2028492", "1000138378", "3011637800", "3010960914", "3006610913", "3016438761", "3030509363", "3002710220", "3000148879", "1717966", "2022180", "3010139432" ], "fei_number": [ "3010692993", "3038196622", "2432235", "3007648367", "3009547954", "1000391282", "1640981", "3006198300", "3013059683", "3043088937", "3043606682", "3008237827", "3016621374", "1000303355", "2936532", "3009596884", "3017439370", "3002806778", "1000125183", "3020305854", "3010188766", "1000442352", "3006461677", "3002805583", "3009746061", "3003559191", "3004859032", "3006606827", "3015614371", "3009000266", "3008505743", "3004140393", "3013043616", "3009189893", "3005333358", "2083544", "3003601075", "3010889707", "3020704087", "3000203293", "3033524192", "3010685493", "3010461097", "3015167933", "3010421384", "3009963993", "3009448641", "3000205059", "3007035884", "3009711478", "2916205", "3001644026", "3005716001", "3014611360", "3002808301", "3043138885", "3006412379", "3027645317", "3003584784", "3019387954", "3016764932", "3003402518", "3006788232", "3003423869", "3014165737", "3003639866", "3031915160", "3038188821", "1000138378", "3011637800", "3007419242", "3010960914", "1000120743", "3006610913", "3016438761", "3030509363", "2244894", "3002710220", "3002179321", "3000148879", "1717966", "2022180", "3010139432" ] } } ] }