{
  "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": "2026-04-22",
    "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": "81024",
      "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": "N/A",
      "distribution_pattern": "International distribution to country of: Jordan",
      "recall_number": "Z-0106-2019",
      "product_description": "\"Free and Total Protein S ELISA Kit\" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 96 Protein S: Ag Microwells,   3 x 0.5mL ELISA Reference Plasma,  1x12 mL Protein S Conjugate Solution,  1 x 60mL Sample Diluent,  1 x 13mL Substrate, 1 x 15mL Stopping Solution, 1 x 30mL Phosphate Buffered Saline, 1 x 2mL Free Protein S Reagent   FOR IN-VITRO DIAGNOSTIC USE  LOT:  3-16- 5292   EXP: 2018-01-26  HELENA LABORATORIES BEAUMONT, TX    Outer labeling of Substrate (brown bottle and cap):  \"Substrate 13 mL\"  FOR IN-VITRO DIAGNOSTIC USE  Store at 2 to 8 C  HELENA LABORATORIES Beaumont, Tx   \"2161421   EXP: 2018-01-26\"    Outer Labeling of Protein S Conjugate bottle (clear bottle and cap, red liquid):  \"Protein S Conjugate 12 mL\" FOR IN-VITRO DIAGNOSTIC USE  Store at 2 to 8 C  HELENA LABORATORIES Beaumont, Tx   \"2161421   EXP: 2018-01-26\"",
      "product_quantity": "3 kits",
      "reason_for_recall": "Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled.  The Protein S Conjugate Solution is  labeled as Substrate, and the Substrate is labeled as Protein S conjugate.",
      "recall_initiation_date": "20170404",
      "center_classification_date": "20181012",
      "termination_date": "20200514",
      "report_date": "20181024",
      "code_info": "3-16-5292; UDI: Primary DI - M52552920"
    }
  ]
}