{
  "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": "177078",
      "product_res_number": "Z-0744-2020",
      "event_date_initiated": "2019-09-16",
      "event_date_created": "2019-12-26",
      "recall_status": "Open, Classified",
      "res_event_number": "84043",
      "product_code": "LPS",
      "k_numbers": [
        "K083222"
      ],
      "product_description": "Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.",
      "code_info": "UDI: 05055845400183; Lot Number 902924815",
      "firm_fei_number": "3002808140",
      "recalling_firm": "Axis-Shield Diagnostics, Ltd.",
      "address_1": "17 Luna Place",
      "city": "Dundee",
      "country": "United Kingdom",
      "reason_for_recall": "There is a potential performance issue as detected by an under-recovery of sample results during routine testing.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Urgent Medical Device Correction notification letters dated 9/16/19 were sent to customers.  \n\nNecessary Actions\nImmediately discontinue use of the affected lots listed and switch to the alternate material lot(s) you may have available in your laboratory.\nImmediately destroy any remaining inventory of the affected lots listed according to your laboratory procedures.\nComplete and return the accompanying verification form\nImmediately order replacement material(s) if you do not have unaffected material available.\nPlease retain this letter for your laboratory records.",
      "product_quantity": "740 total",
      "distribution_pattern": "US Nationwide distribution in the states of CA, KY.",
      "openfda": {
        "k_number": [
          "K992274",
          "K121053",
          "K052788",
          "K011692",
          "K980907",
          "K011689",
          "K071971",
          "K080851",
          "K033706",
          "K073640",
          "K061296",
          "K113793",
          "K013406",
          "K993107",
          "K992858",
          "K032012",
          "K112790",
          "K063701",
          "K123930",
          "K982003",
          "K121533",
          "K030754",
          "K003597",
          "K063206",
          "K061588",
          "K061598",
          "K013606",
          "K062808",
          "K083222"
        ],
        "registration_number": [
          "2432235",
          "9612316",
          "8031673",
          "1319808",
          "3005529799",
          "2032900",
          "1827821",
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          "2250051",
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          "3005333358",
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          "3004493545",
          "3033967997"
        ],
        "fei_number": [
          "3002808328",
          "2432235",
          "3002806559",
          "3005529799",
          "1827821",
          "3002642396",
          "3002809144",
          "3006198300",
          "1219913",
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          "2967",
          "3005333358",
          "3012963943",
          "3004493545",
          "3002806557",
          "3007019572",
          "3033967997"
        ],
        "device_name": "Urinary Homocystine (Nonquantitative) Test System",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1377",
        "device_class": "2"
      }
    }
  ]
}