{ "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": "124646", "product_res_number": "Z-0775-2014", "event_date_initiated": "2013-12-06", "event_date_posted": "2014-01-16", "recall_status": "Terminated", "event_date_terminated": "2014-02-25", "res_event_number": "67065", "product_code": "MVU", "product_description": "Estrogen Receptor AB-11 (Clone ID5)\r\nMouse Monoclonal Antibody\r\n1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA\r\n\r\nThermo Fisher Scientific\r\nAnatomical Pathology\r\nTudor Rd., Manor Park\r\nRancorn, Cheshire WA7 1TA UK\r\n\r\n\r\nAnalyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.", "code_info": "PN/ MS-354-P0, LN 354P1206K; Expiration 03/2015.", "firm_fei_number": "3000719701", "recalling_firm": "Lab Vision Corporation", "address_1": "46117 Landing Pkwy", "city": "Fremont", "state": "CA", "postal_code": "94538-6407", "additional_info_contact": "John Green\n510-979-5000", "reason_for_recall": "Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.", "root_cause_description": "Under Investigation by firm", "action": "Lab Vision Corporation part of Thermo Fisher Scientific sent an Urgent Medical Device Recall letter dated December 6, 2013, to all affected customers. Revised letters will be sent on January 8, 2014. Changes include that the reagent is an Analyte Specific Reagent (ASR) and not an in vitro diagnostic device in the US.\r\n\r\nThey also clarify that a false positive was reported by a customer and a false negative was confirmed during in house testing. Letters also correct the expiry date from 12/2013 to 03/2015. Data sheet was also updated to eliminate information stating that the presence of ER in breast tumors indicates an increased likelihood of response to estrogen therapy and also that the positive control must be determined by the investigator.\r\n\r\nIf you have any questions, please contact Technical Service at 1-800-522-7270, option 2, option 7.", "product_quantity": "5", "distribution_pattern": "Worldwide Distribution: US (nationwide) including the states of TX and MA and internationally to: Turkey.", "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" } } ] }