{ "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": "141086", "product_res_number": "Z-0297-2016", "event_date_initiated": "2015-09-22", "event_date_posted": "2015-11-18", "recall_status": "Terminated", "event_date_terminated": "2016-02-03", "res_event_number": "72427", "product_code": "JQP", "product_description": "Bulk Loader Module for cobas p 512/612\nPre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.", "code_info": "During transport from the Bulk Loader Module (BLM), catalog number 07135645001, to the cobas p 512/p 612 pre-analytical instruments, sample tubes may inadvertently open and spill, causing contamination of the system.", "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": "Todd Siesky\n317-521-3911", "reason_for_recall": "Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.", "root_cause_description": "Device Design", "action": "Roche Diagnostics Operations, Inc. sent an Urgent Medical Device Correction letter to affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were asked to retain the Urgent Medical Device Correction letter until a Roche Field Service Representative has installed the BLM modification kit. Consignees were also asked to complete the attached form and fax to 1-877-906-8982, ext 2015. Consignees with questions were instructed to call 1-800-428-2336.\nFor questions regarding this recall call 317-521-3911.", "product_quantity": "1", "distribution_pattern": "Distributed to TX only.", "openfda": { "k_number": [ "K861778", "K822932", "K781081", "K761063", "K803312", "K801167", "K893838", "K823679", "K801210", "K792158", "K790543", "K881194", "K871853", "K810631", "K964460", "K832746", "K790336", "K801091", "K840502", "K792129", "K781173", "K830296", "K780881", "K822778", "K885292", "K983468", "K802471", "K113007", "K834300", "K823785", "K760739", "K810063", "K770671", "K871339", "K800241", "K832760", "K923316", "K851321", "K831838", "K822381", "K861779", "K801438", "K782052", "K833353", "K934111", "K831574", "K770877", "K823110", "K800242", "K820427", "K800282", "K861844", "K842401", "K802251", "K800724", "K802594", "K821807", "K892060", "K820721", "K812604", "K801664", "K821531", "K831830", "K801131", "K834490", "K821058", "K864557", "K953652", "K822860", "K781217", "K810968", "K854265", "K843365", "K822146", "K861412", "K850659", "K844907", "K853026" ], "registration_number": [ "3013896610", "2432235", "3021394862", "3010900203", "3013298431", "3002809144", "2954323", "3009731198", "3005862821", "3037000637", "3043012240", "3014840402", "3010097171", "3009129531", "3006371704", "3004032053", "3005509212", "9615507", "3040278125", "3043012074", "2517506", "3013922172", "3011194542", "3020978007", "8043909", "3004959793", "3003795116", "3015633428", "9610865", "9610816", "3009288740", "9614673", "3003902721", "3023268435", "3007134734", "3025376092", "2531491", "3003559191", "3006755541", "9615754", "3030413550", "3002637618", "3005798890", "3042228064", "3002821232", "3008802064", "3035708936", "3003453957", "1061932", "1119779", "3015738702", "3009542936", "3031570369", "3042989733", "8020888", "3002807715", "9616530", "3005333358", "1220649", "3012436569", "3010825766", "1810909", "3015426626", "1000113657", "8043723", "3017086896", "9710492", "3004973408", "8020030", "3008514395", "3000126629", "3027496319", "9610126", "3004145393", "3006677029", "2936921", "3003618481", "3009711478", "2243471", "3003825930", "3009404844", "3003995437", "8030392", "3011187792", "3010258456", "3002889627", "3015969360", "3015347724", "3027486032", "3006543086", "3016764932", "1058332", "9616936", "2431530", "1219145", "1225673", "2245451", "3008789114", "2029302", "3030714692", "3024512705", "3038419886", "3012104009", "3016438761", "3012118659", "3015967359", "3002710220", "3015058854", "3013646951", "3000148879", "3011121740", "3010141591", "3011393376", "1950204", "3011806823", "3004838836", "3003600763" ], "fei_number": [ "3013896610", "2432235", "3021394862", "3010900203", "3013298431", "3002809144", "3009731198", "3005862821", "3037000637", "3043012240", "3002808498", "3008237827", "3014840402", "3010097171", "3009129531", "3006371704", "3004032053", "3005509212", "3040278125", "3043012074", "2517506", "3013922172", "3011194542", "3020978007", "3002671736", "3002807167", "3004959793", "3003795116", "3006461677", "3015633428", "3009288740", "3023268435", "3003902721", "3007134734", "3025376092", "3003559191", "3006755541", "3030413550", "3002637618", "3001573851", "3005798890", "3003559576", "3042228064", "3002821232", "3008802064", "3035708936", "3001451449", "3003453957", "3003500908", "1119779", "3015738702", "1000307651", "3009542936", "3031570369", "3042989733", "3002807715", "3005333358", "1220649", "3012436569", "3010825766", "3007019572", "1810909", "3002806350", "3015426626", "3002806559", "1000113657", "3000203293", "3017086896", "3003516723", "3004973408", "3008514395", "3000126629", "3027496319", "3002829675", "3004145393", "3006677029", "2936921", "3003618481", "3002803444", "3009711478", "2243471", "3003116995", "3003825930", "3009404844", "3003995437", "3011187792", "3010258456", "3002889627", "3015969360", "3015347724", "3027486032", "3006543086", "3016764932", "2431530", "1219145", "2245451", "3008789114", "3030714692", "3024512705", "3038419886", "3012104009", "3016438761", "1000306472", "3012118659", "3015967359", "3002710220", "3015058854", "3013646951", "3010700165", "3000148879", "3010141591", "3011393376", "1950204", "3011806823", "3004838836", "3003600763" ], "device_name": "Calculator/Data Processing Module, For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2100", "device_class": "1" } } ] }