{ "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": "143258", "product_res_number": "Z-0851-2016", "event_date_initiated": "2016-01-25", "event_date_created": "2016-02-23", "recall_status": "Terminated", "event_date_terminated": "2016-10-18", "res_event_number": "73155", "product_code": "MVU", "product_description": "BD FMC7 FITC: Model 430918.\nFMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.\n\nProduct Usage:\nAnalyte Specific Reagent. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.", "code_info": "Model number: 340918: Lot number: 5341918. Incorrect expiry date on label 03/31/2017. correct expiry should be 6/30/16.", "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": "Melissa J. Quinn\n408-954-6080", "reason_for_recall": "Becton,\nDickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expiration date listed\non the vial label.", "root_cause_description": "Under Investigation by firm", "action": "BD Biosciences sent an Urgent Medical Device Recall letters dated January 2016 via certified mail to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed that the remaining stock of the product can be used until 6-30-16. however, if prefer they can discard all remaining stock of the affected lot and BD will replace.\nThe letter request customers complete the Tracking/verification form and returned to BD Biosciences, per the instructions (mail, fax, or email).\nFor questions contact your local BD representative or BD Customer Support at 877-232-8995 (prompt 3,3).", "product_quantity": "78", "distribution_pattern": "Worldwide Distribution - US Nationwide in the staates of TX, NY, GA, NJ, AL, MA, IL, PA, DC, FL, CA, MD, OK. and coutry of Taiwan.", "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" } } ] }