{
  "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 III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81303",
      "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": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) to states of: GA, IN, and MI, and countries of: Australia, Brazil, Canada, Japan and Hong Kong.",
      "recall_number": "Z-0529-2019",
      "product_description": "Gel Alkaline Phosphatase Isoenzyme Control Kit:    Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE    Gel Alkaline Phosphatase Isoenzyme Control  20mL  001831     Alkaline Phosphatase Isoenzyme Control is to be used as a qualitative and/or quantitative control to aid in the identification of alkaline Phosphatase isoenzymes by electrophoresis.",
      "product_quantity": "43 kits (6 kits Domestic/37 Internationally)",
      "reason_for_recall": "Due to a customer experiencing complaints on  bone  fraction of assay not being in range.  The complaint: ~12% lower enzyme activity was noted.",
      "recall_initiation_date": "20161107",
      "center_classification_date": "20181130",
      "termination_date": "20210115",
      "report_date": "20181212",
      "code_info": "\" Lot Codes: 1-16-5104  (Scheme:  1(st lot)-(of 20)16-(for C/N )5104)  \" Model/Catalog Number: 5104  \" UDI: Primary DI - M52551040"
    }
  ]
}