{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Westlake",
      "address_1": "810 Sharon Dr",
      "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.   The 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.   HemoCue Glucose 201 Microcuvettes are for In Vitro Diag",
      "address_2": "",
      "product_quantity": "3,712,900 microcuvettes",
      "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     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,      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       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         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",
      "center_classification_date": "20141224",
      "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.",
      "state": "OH",
      "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.   Affected lots identified initially were 110705, 110706, 110715, 110716, 110717, 110718, 110719, and 110720.  Subsequent investigation also identified as affected lots 1310227, 1310252, and 1310257.    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.",
      "report_date": "20141231",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Radiometer America Inc",
      "recall_number": "Z-0873-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "69663",
      "termination_date": "20151002",
      "more_code_info": "",
      "recall_initiation_date": "20141020",
      "postal_code": "44145-1521",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}