{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "193176", "product_res_number": "Z-1214-2022", "event_date_initiated": "2022-03-25", "event_date_created": "2022-06-01", "recall_status": "Open, Classified", "res_event_number": "90028", "product_code": "MVU", "product_description": "BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry.", "code_info": "Lot # 1064663; UDI: 00382903410989", "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": "North Americal Regional Complaint Center\n1844-823-5499", "reason_for_recall": "Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.", "root_cause_description": "Process control", "action": "On April 20, 2022, BD Biosciences issued a \"Urgent Product Recall\" notification via FeDEx to affected consignees. The firm ask consignees to take the following actions: \n\n1. Immediately review your inventory for the specific Catalog and lot numbers listed above. Destroy all product subject to the recall following your institution s process for destruction.\n\n2. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall.\n\n3. If the product was used in LDTs to generate patient results, please also review potential impact to patient results following your institution s policies.\n\n4. Complete the attached Customer Response Form and return to the BD contact noted on the form. Even if you do not have any of the affected lots in your inventory, please complete the Customer Recall Response Form indicating you have zero (0) quantity and return as indicated.\n\n5. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via the: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) or Mail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787", "product_quantity": "249 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, DC, DE, FL, IA, IL, IN, LA, MA, MD, ME, MI, MN, MO, NC, ND, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and the country of Taiwan.", "openfda": { "registration_number": [ "3008576040", "3007799234", "1122376", "3017439370", "3005626422", "1711690", "3004140393", "3007738260", "2022180", "1025402", "2914537", "3017212430", "1000191380", "2028492", "3006371704", "3010534606", "3008773547", "3004013603", "3004074729", "8043909", "9681630", "3009389940", "2032839", "3008272746", "3009236983", "3006532105", "3030442070", "3003521949", "3031606509", "2023365", "2083544", "2024800", "2016473", "3008264130", "3014429566", "3007143373", "3007701857", "3012104694", "3005290010", "3013059683", "2025606", "3004153557", "3013710310", "3003485232", "2090110", "9610566", "2020952", "3012129445", "3014766585", "3005060031", "1061932", "2026994", "3003423869", "3008096179", "3010033384", "3004493545", "9610099", "3009189893", "3003335080", "9710378", "3036495171", "3014173060", "3039353646", "3015376545", "3010139432", "3042250641", "3031915160", "3011240982", "9611882", "3003540236", "3009672007", "3008794764", "3005248192", "3009711478", "9614373", "3007035884", "3011873748", "8030124", "1627497", "3004859032", "3027518847", "3004973408", "3032562", "3008776165", "1124976", "1017835", "3016954941", "3010890428", "3011279282", "3015292643", "1119779", "9681582", "3009869675", "3015614371", "3042898196", "8023060", "3017237798", "3011781554", "3011310310", "3004375571", "3009161685", "8010134", "3013043616", "9610240", "1649339", "3027062375", "2916205", "3008849407", "3015258926", "2182595", "3014165737", "3027394506", "8023018", "3007208259", "3008352382", "3002821232", "3012471076" ], "fei_number": [ "3008576040", "3007799234", "3005853611", "3017439370", "3005626422", "1711690", "3004140393", "3007738260", "2022180", "1025402", "2914537", "3002606748", "3000203293", "3017212430", "1000191380", "3006371704", "3002646096", "3010534606", "3008773547", "3004013603", "3004074729", "3000719564", "3002808498", "3009389940", "3008272746", "3009236983", "3003572099", "3000718726", "3006532105", "3030442070", "3003521949", "3031606509", "2023365", "2083544", "2024800", "3008264130", "3014429566", "3007143373", "3002808845", "3012104694", "3013059683", "2025606", "3004153557", "3013710310", "3003485232", "3002807272", "3004112148", "2020952", "3002346973", "3012129445", "3014766585", "3005060031", "2026994", "3003423869", "3008096179", "3010033384", "3004493545", "3009189893", "3003335080", "3036495171", "3002806778", "3014173060", "3039353646", "3015376545", "3010139432", "3042250641", "3031915160", "1000125787", "3011240982", "3003540236", "3009672007", "3008794764", "3005248192", "3009711478", "3007035884", "3000178900", "3011873748", "1627497", "3004859032", "3027518847", "3004973408", "1017835", "3016954941", "3010890428", "3011279282", "3015292643", "1119779", "3009869675", "3015614371", "3042898196", "3002808078", "3017237798", "3011781554", "3011310310", "3004375571", "2936532", "3009161685", "3013043616", "3027062375", "3004185580", "2916205", "1000125183", "3003992026", "3003206361", "3008849407", "3002808212", "3015258926", "2182595", "3014165737", "3002807541", "3027394506", "3002807876", "3002808340", "3008352382", "3007208259", "3002821232", "3012471076" ], "device_name": "Reagents, Specific, Analyte", "medical_specialty_description": "Pathology", "regulation_number": "864.4020", "device_class": "1" } } ] }