{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "120868",
      "product_res_number": "Z-0101-2014",
      "event_date_initiated": "2013-07-25",
      "event_date_posted": "2013-10-29",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-08-11",
      "res_event_number": "65920",
      "product_code": "GKR",
      "k_numbers": [
        "K032203"
      ],
      "product_description": "HemoCue Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden",
      "code_info": "Part Number 111715: Lot numbers1208655, 1208658, 1208659, 1208660, 1208663, 1208664, 1209667, 1209669, 1209670, 1209671, 1209672, 1209674, 1209675, 1209677, 1209678, 1210681, 1210683, 1210685, 1210688, 1211690, 1211691, 1211692, 1211694, 1211696, 1211697, 1211699, 1212701, 1212702, 1212703, 1212705, 1212706, 1301708, 1301710, 1301711, 1301712, 1301715, 1301717, 1301719, 1302721, 1302723, 1302725, 1302726, 1303729, 1303734 &  1304737.   Part Number 111717: Lot Numbers: 1208657, 1208661, 1208662, 1208665, 1209666, 1209668, 1209673, 1209676, 1210679, 1210680, 1210682, 1210684, 1210686, 1210689, 1211693, 1211695, 1211698, 1212700, 1212704, 1212707, 1301709, 1301713, 1301714, 1301716, 1301718, 1302720, 1302722, 1302724 & 1304738.   Part Number 111722: Lot numbers: 1209672, 1210687, 1212701 & 1303727.  Part Number 116101; Lot Numbers: 1303730 & 1303735.",
      "firm_fei_number": "3003044483",
      "recalling_firm": "HemoCue AB",
      "address_1": "Kuvettgaten 1 1 kuvettgaten",
      "city": "Angelholm",
      "country": "Sweden",
      "additional_info_contact": "Mr. Shane T. Hawes\n440-871-0463",
      "reason_for_recall": "HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches.",
      "root_cause_description": "Packaging",
      "action": "On 8/13/2013 the firm sent Field Safety Notices to their customers.",
      "product_quantity": "42,330 packages/4 boxes/25 microcuvetes",
      "distribution_pattern": "Worldwide distribution which includes the following states: AK, AL, AS, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY,MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, WA, WI, VT, WV & WY\nand the countries of  Armenia, Australia, Austria, Belgium, Cyprus, Czech Republic, Denmark, El Salvador Finland, France, Germany, Great Britain, Guatemala, Hong Kong, Israel, Ivory Coast, Netherlands, New Zealand, Norway, Peru, Poland, Russia, South Africa, Sweden, Switzerland and Taiwan.",
      "openfda": {
        "k_number": [
          "K803016",
          "K110393",
          "K090093",
          "K832020",
          "K081719",
          "K163465",
          "K961312",
          "K803015",
          "K061047",
          "K182298",
          "K781361",
          "K945677",
          "K200909",
          "K172173",
          "K880353",
          "K841057",
          "K954018",
          "K865055",
          "K020710",
          "K771789",
          "K850096",
          "K870210",
          "K831618",
          "K802266",
          "K181751",
          "K850094",
          "K910745",
          "K121752",
          "K780829",
          "K201217",
          "K790030",
          "K020616",
          "K812127",
          "K023561",
          "K041234",
          "K032482",
          "K122553",
          "K031898",
          "K032203"
        ],
        "device_name": "System, Hemoglobin, Automated",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.5620",
        "device_class": "2",
        "registration_number": [
          "3030733800",
          "3003044483",
          "1616487",
          "3012494290",
          "3013513377",
          "3004102403",
          "3005146144",
          "3043226252",
          "2531491",
          "1219029",
          "3002807968",
          "1649661",
          "9610633",
          "9610126",
          "3007490412",
          "1217183",
          "3023162659",
          "1220649",
          "1219913",
          "3037000637",
          "3003795116",
          "9615507",
          "3009491259",
          "3002637618",
          "2431530",
          "2432235",
          "2244821",
          "3006198300",
          "3004838836",
          "3014506106"
        ],
        "fei_number": [
          "3030733800",
          "3003044483",
          "3003516723",
          "1616487",
          "3012494290",
          "3013513377",
          "3004102403",
          "3005146144",
          "3043226252",
          "1219029",
          "3002807968",
          "3002806693",
          "3007490412",
          "3002829675",
          "1217183",
          "3002806559",
          "3023162659",
          "1220649",
          "1219913",
          "3037000637",
          "3003795116",
          "3009491259",
          "3002637618",
          "2431530",
          "2432235",
          "2244821",
          "3001451797",
          "3006198300",
          "3004838836",
          "3014506106"
        ]
      }
    }
  ]
}