{ "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": "149794", "product_res_number": "Z-0128-2017", "event_date_initiated": "2016-09-21", "event_date_created": "2016-10-18", "recall_status": "Terminated", "event_date_terminated": "2016-12-27", "res_event_number": "75250", "product_code": "MVU", "product_description": "CD79b PE (ASR) , Catalog number 335816 ;\n\nHematology:\nThe CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig) antigen receptors are composed of a non-covalently associated complex of Ig and two other proteins, Iga and Igb, which have been designated as CD79a and CD79b, respectively.\n antigen", "code_info": "Lot number: 5348570; Expiration Date: 31 July 2017", "firm_fei_number": "2916837", "recalling_firm": "Becton, Dickinson and Company, BD Biosciences", "address_1": "2350 Qume Dr", "city": "San Jose", "state": "CA", "postal_code": "95131-1812", "additional_info_contact": "Mellissa J/ Quinn\n408-954-6307", "reason_for_recall": "CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity", "root_cause_description": "Under Investigation by firm", "action": "BD Life Sciences sent an Urgent Product recall letter dated September 2016 on September 21, 2016 ,to all affected customers via UPS and/or e-mail. Customers were instructed to inspect their inventory to determine if they have any of the affected lots and to discard the affected lots, and BD will issue replacement product. Customers were also instructed to complete the attached Customer Response Form whether or not they have any affected product. Customers needing further assistance should contact BD Customer Support at 855-236-2772 (prompt 3). For customers outside the US, contact their local BD Biosciences representative or distributor.\nFor questions regarding this recall call 408-954-6307.", "product_quantity": "14 units", "distribution_pattern": "Nationwide Distribution to CA, MN, OH and TX.", "openfda": { "registration_number": [ "3009161685", "2182595", "2024800", "3013059683", "3003540236", "3007143373", "1025402", "3016954941", "9681630", "3006371704", "3008849407", "3009389940", "3009236983", "2016473", "3017237798", "3008272746", "3008264130", "3017439370", "9611882", "8030124", "3005290010", "3008096179", "8043909", "3042250641", "8010134", "2020952", "3036495171", "8023060", "3010890428", "3004153557", "9610566", "3009672007", "3011279282", "2023365", "3015292643", "3012104694", "3004859032", "1627497", "3013710310", "3008794764", "3008773547", "1649339", "3002821232", "3030442070", "1061932", "3011781554", "1119779", "3015614371", "3003485232", "3004140393", "1017835", "3012129445", "3013043616", "3009189893", "3004493545", "2083544", "3027394506", "2914537", "2026994", "8023018", "3004375571", "3012471076", "9610099", "3042898196", "3004013603", "3008576040", "3007799234", "3004973408", "3007208259", "1000191380", "3009869675", "2090110", "3014766585", "3007035884", "3004074729", "3009711478", "3011310310", "9610240", "1122376", "2916205", "2032839", "3031606509", "1124976", "3027518847", "3014173060", "9710378", "3027062375", "3005060031", "3015258926", "3005248192", "3005626422", "3008776165", "3011240982", "3014429566", "3003423869", "3014165737", "3011873748", "1711690", "3031915160", "2028492", "3010534606", "3007701857", "3007738260", "3003521949", "3017212430", "2025606", "3010033384", "9614373", "3032562", "3003335080", "3006532105", "3015376545", "9681582", "2022180", "3039353646", "3010139432", "3008352382" ], "fei_number": [ "3009161685", "3003992026", "3004112148", "2182595", "3003206361", "2024800", "3013059683", "3003540236", "3007143373", "3002808498", "1025402", "3016954941", "3006371704", "3008849407", "3009389940", "3009236983", "3017237798", "3008272746", "2936532", "3008264130", "3017439370", "3002806778", "1000125183", "3008096179", "3042250641", "2020952", "3036495171", "3010890428", "3004153557", "3000718726", "3003572099", "3002606748", "3009672007", "3011279282", "3002807272", "3000178900", "2023365", "3015292643", "3012104694", "3004859032", "1627497", "3013710310", "3008794764", "3008773547", "3002646096", "3002821232", "3030442070", "3002808078", "3011781554", "1119779", "3015614371", "3003485232", "3004140393", "1017835", "3012129445", "3002808212", "3013043616", "3009189893", "3004493545", "2083544", "3027394506", "2914537", "2026994", "3000203293", "3004375571", "3012471076", "3042898196", "3004013603", "3008576040", "3007799234", "3004973408", "3007208259", "1000191380", "3009869675", "1000125787", "3014766585", "3007035884", "3004074729", "3009711478", "3002808340", "3011310310", "3000719564", "2916205", "3031606509", "3027518847", "3014173060", "3027062375", "3005060031", "3015258926", "3005248192", "3005626422", "3014429566", "3011240982", "3003423869", "3014165737", "3011873748", "1711690", "3031915160", "3010534606", "3004185580", "3002807541", "3002808845", "3007738260", "3003521949", "3002346973", "3017212430", "2025606", "3010033384", "3005853611", "3003335080", "3006532105", "3015376545", "2022180", "3039353646", "3002807876", "3010139432", "3008352382" ], "device_name": "Reagents, Specific, Analyte", "medical_specialty_description": "Pathology", "regulation_number": "864.4020", "device_class": "1" } } ] }