{ "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": "131292", "product_res_number": "Z-0873-2015", "event_date_initiated": "2014-10-20", "event_date_posted": "2014-12-24", "recall_status": "Terminated", "event_date_terminated": "2015-10-02", "res_event_number": "69663", "product_code": "CGA", "k_numbers": [ "K020935" ], "product_description": "HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. \nAffected lots identified initially were 110705, 110706, 110715, 110716, 110717, 110718, 110719, and 110720. Subsequent investigation also identified as affected lots 1310227, 1310252, and 1310257.\n\nHemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials.", "code_info": "Model Number 110705:  Lot numbers: 1310500, 1310501, 1310502, 1310503, 1310518, 1310519, 1310520, 1310521, 1310767, 1310768, 1310769, 1310770, 1310771, 1310772, 1310779, 1310780, 1310781, 1310788, 1310789, 1310790, 1310799, 1311524, 1311525, 1311526, 1311527, 1311528, 1311529, 1311530, 1311531, 1311532, 1311533, 1311534, 1311535, 1311536, 1311537, 1311538, 1311539, 1311541, 1311542\t  Model Number 110706: Lot numbers: 1310207, 1310208, 1310209, 1310210, 1310211, 1310212, 1310213, 1310214, 1310215, 1310216, 1310228, 1310231, 1310232, 1310234, 1310235, 1310238, 1310239, 1310247, 1310249, 1310250, 1310256, 1310257, 1310258, 1310259, 1310260, 1311270, 1311271, 1311272, 1311273, 1311274, 1311279, 1311280, 1311281, 1311282, 1311283, 1311284, 1311291, 1311296, 1311297, 1311314, 1311315, 1311316, 1311317, 1311318, \t  Model Number 110715: Lot numbers: 1310217, 1310218, 1310219, 1310221, 1310222, 1310229, 1310230, 1310237, 1310240, 1310241, 1310242, 1310251, 1310252, 1311267, 1311268, 1311269, 1311298, 1311301, 1311302, 1311303, 1311304, 1311321, 1311322, 1311323, 1311324  Model Number 110716: Lot numbers: 1310202, 1310203, 1310204, 1310223, 1310224, 1310225, 1310227, 1310243, 1310244, 1310245, 1310246, 1310261, 1311263, 1311264, 1311265, 1311266, 1311277, 1311278, 1311305, 1311306, 1311307, 1311308, 1311309, 1311310, 1311311, 1311312, 1311313, 1311325\t \t  Model Number 110717: Lot numbers: 1310504, 1310505, 1310506, 1310507, 1310508, 1310509, 1310510, 1310514, 1310515, 1310516, 1310517, 1310773, 1310774, 1310775, 1310776, 1310783, 1310784, 1310785, 1310791, 1310792, 1310794, 1310795, 1310796, 1311540, 1311543, 1311544, 1311545\t \t \t  Model Number 110718: Lot numbers: 1310511, 1310512, 1310513, 1310777, 1310778, 1310786, 1310787, 1310797, 1310798  Model Number 110719: Lot numbers: 1310236, 1310237, 1310248, 1311285, 1311286, 1311287, 1311288, 1311289, 1311290, 1311292, 1311293, 1311294, 1311295, 1311299, 1311300  Model Number 110720: Lot numbers: 1310205, 1310206, 1310226, 1310253, 1310254, 1310255, 1311319, 1311320", "firm_fei_number": "1523456", "recalling_firm": "Radiometer America Inc", "address_1": "810 Sharon Dr", "city": "Westlake", "state": "OH", "postal_code": "44145-1521", "additional_info_contact": "Matthew R. Ackerman\n440-871-8900 Ext. 53485", "reason_for_recall": "Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the specification at the end of their shelf life, approx. after 6 months. \nThe HemoCue Glucose 201 Analyzer with plasma conversion multiplies the measured whole blood glucose value by a factor of 1.11 and displays a plasma equivalent glucose result. \nHemoCue Glucose 201 Microcuvettes are for In Vitro Diag", "root_cause_description": "Under Investigation by firm", "action": "The consignees will be notified by a Field Safety Notice. Distributors will be instructed to forward the Field Safety Notice to their end customers and to secure that verification forms will be filled-out by end customers and returned to HemoCue.", "product_quantity": "3,712,900 microcuvettes", "distribution_pattern": "Worldwide Distribution-US (nationwide) and the countries of Canada, Austria, AUSTRALIA, SWITZERLAND, COTE D'IVOIRE, CYPRUS, CZECH REPUBLIC, GERMANY, DENMARK, FINLAND, FRANCE, UNITED KINGDOM, GEORGIA, HONG KONG, CROATIA, HUNGARY, IRELAND, INDIA, ICELAND, JAPAN, KENYA, MACEDONIA, MALTA, NETHERLANDS, NORWAY, NEPAL, NEW ZEALAND, POLAND, ROMANIA, RUSSIA, SWEDEN, SLOVENIA, UNITED REPUBLIC OF TANZANIA, and SOUTH AFRICA.", "openfda": { "k_number": [ "K003346", "K024014", "K936212", "K771754", "K915772", "K781307", "K000365", "K913357", "K002688", "K962295", "K884909", "K002621", "K813168", "K811882", "K822976", "K911141", "K082965", "K923048", "K761153", "K210958", "K973140", "K103842", "K842393", "K960034", "K761060", "K963535", 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"K182781", "K854260", "K904168", "K872049", "K934892", "K926360", "K000583", "K951457", "K082417", "K984527", "K923587" ], "pma_number": [ "P990026" ], "registration_number": [ "3005621222", "3012133212", "2027969", "2432235", "1550101", "3016525500", "3006198300", "3005862821", "3037000637", "3015967131", "3045752480", "3010097171", "2939693", "3009129531", "3006371704", "3011979858", "3004009431", "3006532271", "9615507", "3021611414", "3013223546", "3023162659", "3022147580", "3015109923", "3008780388", "3020978007", "1319681", "2050010", "9611444", "3004959793", "3003795116", "1649661", "1319809", "3010830834", "3005146144", "3004043187", "3003902721", "3004637226", "3007134734", "3003044483", "2531491", "3006755541", "3026260647", "3012104670", "3018940143", "3002637618", "3014506106", "3013472743", "3011989923", "3007490412", "3013957847", "3011065399", "2245578", "3013160357", "3005146313", "1832216", "3021841051", "3004102403", "9616530", "3012817228", "3012963943", 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