{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "183670", "product_res_number": "Z-0086-2021", "event_date_initiated": "2020-08-31", "event_date_created": "2020-10-08", "recall_status": "Open, Classified", "res_event_number": "86399", "product_code": "KPA", "product_description": "DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only)\nMaterial Number: 05987750001", "code_info": "All units", "firm_fei_number": "1823260", "recalling_firm": "Roche Diagnostics Operations, Inc.", "address_1": "9115 Hague Rd", "city": "Indianapolis", "state": "IN", "postal_code": "46256-1025", "additional_info_contact": "Drew Hodge\n317-521-4343", "reason_for_recall": "Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket", "root_cause_description": "Device Design", "action": "Roche issued Urgent Medical Device Correction letter on 8/31/20 via UPS Ground Receipt stating: reason for recall, health risk and action to take: actions below.\n\" Inform any operators that use the BenchMark ULTRA and DISCOVERY ULTRA instruments of the\npotential hazards associated with this issue and provide a copy of this notification as appropriate.\n\" Inspect the instrument daily for evidence of leaks (i.e., liquid outside of the waste reservoir, liquid on the floor, liquid on the skin/outer panel of the instrument).\n\" If you experience a fluid leak, stop using the system and turn off the power to the instrument. Immediately contact the Roche Support Network Customer Support Center at 1-800-227-2155.\n\" Complete the attached fax back form (TP-01057) and fax or email it according to the instructions on the form.\n\" If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site.\n\" File this UMDC for future reference\n\nLocal Field Engineering Specialists (FESs) will perform specific service actions, including the completion of the Waste Tub and Filter Upgrade (if it has not already been implemented), inspection of specific\ninstrument parts for signs of cracks and fluid leaks, and installation of a power connector shield, which will prevent fluid entry into the power cord connection and socket.\n\nContact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-227-2155 if you have questions about the information contained in this UMDC.", "product_quantity": "257 (US); 208 (ex-US)", "distribution_pattern": "Nationwide\nForeign:\nCanada, \nAustria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, UK,\nAlgeria, Argentina, Aruba, Australia, Bahrain, Bosnia-Herz., Brazil, Chile, China, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, Egypt, El Salvador, Hong Kong, India, Israel, Japan, Jordan, Kazakhstan, Kuwait, Malaysia, Martinque, Mexico, Monaco, Morocco, Namibia, New Caledonia, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Russia, Saudi Arabia, Singapore, S. Africa, S. Korea, Taiwan, Thailand, Ukraine, UAE, Vietnam", "openfda": { "k_number": [ "K833295", "K933996", "K884258", "K842077", "K850157", "K821830", "K850333", "K872916", "K780017", "K832994", "K771699", "K780637", "K874897", "K881592", "K874887", "K770076", "K781598", "K880745", "K853210", "K771559", "K811697" ], "device_name": "Slide Stainer, Automated", "medical_specialty_description": "Pathology", "regulation_number": "864.3800", "device_class": "1", "registration_number": [ "1000303355", "3007035884", "1640981", "3005716001", "3010960914", "2432235", "1717966", "3009448641", "1222780", "9613959", "1000138378", "3027645317", "3014165737", "2028492", "3003584784", "3043138885", "3030509363", "3033524192", "3006198300", "2083544", "3009963993", "3031915160", "3038196622", "3008776165", "3009596884", "3019387954", "3010461097", "3017439370", "3006788232", "3003639866", "1063851", "3015167933", "3016764932", "3006610913", "3009432145", "3010889707", "3013043616", "3020305854", "9615754", "9680927", "3014611360", "3043606682", "3011637800", "2030652", "3007648367", "3009547954", "3004140393", "3016438761", "3016621374", "1061932", "3002805583", "3003423869", "9610806", "3010421384", "3009711478", "3005333358", "3003559191", "3006606827", "3015614371", "3002710220", "3020704087", "3009000266", "8010478", "1000391282", "3043088937", "2022180", "9610099", "3013059683", "3008505743", "3010188766", "8020030", "3003402518", "3006412379", "3004859032", "3010139432", "3009189893", "3009746061", "3038188821", "3000148879", "2916205", "3010685493", "3010692993", "3003601075" ], "fei_number": [ "1000125183", "1000303355", "3007035884", "3000205059", "1640981", "3005716001", "3010960914", "2432235", "1717966", "3009448641", "1000138378", "2936532", "1000120743", "3027645317", "3014165737", "2244894", "3003584784", "3030509363", "3043138885", "3033524192", "3006198300", "2083544", "3009963993", "3031915160", "3038196622", "3006461677", "3009596884", "3019387954", "3010461097", "3017439370", "3006788232", "3003639866", "3015167933", "3016764932", "3002806778", "3007419242", "3002808301", "3006610913", "3010889707", "3013043616", "3020305854", "3014611360", "3043606682", "3011637800", "3007648367", "3009547954", "3004140393", "1000442352", "3016438761", "3016621374", "3002805583", "3003423869", "3010421384", "3009711478", "3005333358", "3003559191", "3006606827", "3015614371", "3002710220", "3020704087", "3009000266", "1000391282", "3043088937", "2022180", "3013059683", "3008505743", "3000203293", "3010188766", "3008237827", "3003402518", "3006412379", "3004859032", "3010139432", "3009189893", "3009746061", "3038188821", "3000148879", "3002179321", "2916205", "3010685493", "3001644026", "3010692993", "3003601075" ] } } ] }