{
  "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": [
    {
      "status": "Terminated",
      "city": "Beaumont",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81383",
      "recalling_firm": "Helena Laboratories, Inc.",
      "address_1": "1530 Lindbergh Dr",
      "address_2": "N/A",
      "postal_code": "77707-4131",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Domestic: FL, IL, MN, MT, NY, OH, TN, TX, VA, and WI     OUS:  Australia, Canada, Jordan, and South Korea",
      "recall_number": "Z-2434-2019",
      "product_description": "Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL",
      "product_quantity": "65 kits",
      "reason_for_recall": "Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.",
      "recall_initiation_date": "20161014",
      "center_classification_date": "20190830",
      "termination_date": "20231012",
      "report_date": "20190911",
      "code_info": "Lot Codes: 1-16-5136 (Scheme:  1(st lot)-(of 20)16-(for C/N )5136)    LOT 1-16-5136  EXP 3-17    Model/Catalog Number: 5136    UDI: Primary DI - M52551360"
    }
  ]
}