{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "180494",
      "product_res_number": "Z-2192-2020",
      "event_date_initiated": "2020-03-23",
      "event_date_created": "2020-05-29",
      "recall_status": "Open, Classified",
      "res_event_number": "85313",
      "product_code": "PDJ",
      "k_numbers": [
        "K180296",
        "K182988"
      ],
      "product_description": "Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970, 1116971, 1116985, 1116986, IVD.  The firm name on the label is Abbott Diagnostics Technologies AS, Oslo, Norway.\n\nPower supply provided with Alere Afinion AS100 Analyzer, Catalog numbers 1115175, 1115390, 1116049, 1116050, 1116053, 1116054, 1116456, and 1116980.  The firm name on the label is Alere Technologies AS, Oslo, Norway.",
      "code_info": "All serial numbers are affected.",
      "firm_fei_number": "3003045237",
      "recalling_firm": "Abbott Diagnostics Technologies AS",
      "address_1": "Kjelsaasveien 161 Kjelsaasveien",
      "city": "Oslo",
      "postal_code": "161",
      "country": "Norway",
      "additional_info_contact": "866-2169505",
      "reason_for_recall": "The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional.",
      "root_cause_description": "Device Design",
      "action": "The recalling firm/manufacturer issued medical device correction letters dated 3/23/2020 on 3/23/2020 to their direct distributors requesting end user customer information.  The recalling firm/manufacturer issued medical device correction letters to the end users dated 3/31/2020 via a third-party notification firm.  The notification informed the end user of the issue and requested to be notified of the number of power supplies needed for replacement.  The affected power supplies were to be discarded by the end user.",
      "product_quantity": "42,237 instruments",
      "distribution_pattern": "Distribution was made to NJ.  There was no direct government/military distribution.\n\nForeign distribution was made to Canada, Argentina, Australia, Bangladesh, Brazil, Cambodia, Chile, China, Colombia, Denmark, Finland, France, Georgia, Germany, Guatemala, Hong Kong, Iceland, India, Italy, Ivory Coast, Japan, Korea, Madagascar, Malaysia, Mexico, Mongolia, Myanmar, The Netherlands, Norway, Oman, Pakistan, Peru, Philippines, Poland, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Timur, Trinidad & Tobago, United Kingdom, and Zimbabwe.",
      "openfda": {
        "k_number": [
          "K142595",
          "K131580",
          "K252749",
          "K220999",
          "K200256",
          "K140654",
          "K171537",
          "K161687",
          "K182651",
          "K250073",
          "K180296",
          "K200904",
          "K171861",
          "K121610",
          "K151321",
          "K160571",
          "DEN130002",
          "K142448",
          "K171771",
          "K182988",
          "K173206",
          "K193053",
          "K130255",
          "K173909",
          "K162822",
          "K242911"
        ],
        "registration_number": [
          "3043149833",
          "1319681",
          "3003422726",
          "3002809144",
          "8020316",
          "9614673",
          "2432235",
          "3005529799",
          "1319808",
          "3043654757",
          "3004529019",
          "8023024",
          "3002642396",
          "1832816",
          "8031673",
          "3016438761",
          "3000308930",
          "3009448641",
          "3003539867",
          "3012963943",
          "2027969",
          "2050012",
          "2250051",
          "2915274",
          "9680746",
          "3006421415",
          "9610126",
          "3005333358",
          "1319809",
          "2517506",
          "9611444",
          "2032682",
          "1000487132",
          "9613069"
        ],
        "fei_number": [
          "3002806559",
          "3043149833",
          "1000206808",
          "3003422726",
          "3002809144",
          "2432235",
          "6387",
          "3005529799",
          "3002806809",
          "3043654757",
          "3004529019",
          "1000305840",
          "3002642396",
          "1832816",
          "3016438761",
          "3000308930",
          "3003045237",
          "3009448641",
          "1000125596",
          "3012963943",
          "2050012",
          "2250051",
          "2915274",
          "3002807423",
          "3006421415",
          "3005333358",
          "2967",
          "3003559576",
          "2517506",
          "1000136573",
          "1000305841",
          "3003952975",
          "1000487132",
          "3006769061"
        ],
        "device_name": "Hemoglobin A1c Test System",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1373",
        "device_class": "2"
      }
    }
  ]
}