{ "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": "196769", "product_res_number": "Z-0353-2023", "event_date_initiated": "2022-10-27", "event_date_posted": "2022-12-01", "recall_status": "Terminated", "event_date_terminated": "2024-12-27", "res_event_number": "91117", "product_code": "MVU", "product_description": "CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy.\nThis device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on chromosome 14.\nRef: MPD39781", "code_info": "Lot RD22/230/10", "firm_fei_number": "3002646096", "recalling_firm": "Cytocell Ltd.", "address_1": "418 Cambridge Science Park, Milton Road 418 gene technology cambridge science park milton road", "city": "Cambridge", "country": "United Kingdom", "reason_for_recall": "Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in version 1 of the package insert is incorrect and doesn't not match the probe design or specification contained on the package insert", "root_cause_description": "Under Investigation by firm", "action": "Cytocell issued Urgent Medical Device Recall letter on 10/27/22 to the end-user via email. Letter states reason for recall, health risk and action to take:\nImmediately examine your inventory and quarantine all product subject to recall.\nCytocell requests that all users review and implement the enclosed new package insert (v2) for this device. Please dispose of any copies of v1 of the package insert.\nOnce implemented, all devices can continue to be used as the device itself has not malfunctioned. \nPlease complete and return the enclosed response form as soon as possible.\nIf you have any questions, contact Cytocell on Tel: +44 (0)1223 294048, Fax +44(0)1223 294986 or vigilance@ogt.com.", "distribution_pattern": "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" } } ] }