{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Dundee",
      "state": "",
      "country": "United Kingdom",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84043",
      "recalling_firm": "Axis-Shield Diagnostics, Ltd.",
      "address_1": "17 Luna Place",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of CA, KY.",
      "recall_number": "Z-0743-2020",
      "product_description": "Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - 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.",
      "product_quantity": "740 total",
      "reason_for_recall": "There is a potential performance issue as detected by an under-recovery of sample results during routine testing.",
      "recall_initiation_date": "20190916",
      "center_classification_date": "20191226",
      "report_date": "20200101",
      "code_info": "UDI: 05055845400169; Lot Number 902924526",
      "more_code_info": ""
    }
  ]
}