{
  "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": "Terminated",
      "city": "Murray",
      "state": "UT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86255",
      "recalling_firm": "Clinical Innovations, LLC",
      "address_1": "747 W 4170 S",
      "address_2": "N/A",
      "postal_code": "84123-1364",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US:  CO, IL, IN, MO, OH, RI, UT, and VA.    OUS: None",
      "recall_number": "Z-0541-2021",
      "product_description": "Clinical Innovations ROM Plus Collection Kit    IFU:  ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025",
      "product_quantity": "19450 units/kits",
      "reason_for_recall": "Possible false negative or false positive results.  The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro diagnostic kits.   If the user does not break the swab stick correctly, or if scissors or other tools are used to cut the swab handle false negative or false positive results can occur.",
      "recall_initiation_date": "20200813",
      "center_classification_date": "20201207",
      "termination_date": "20240524",
      "report_date": "20201216",
      "code_info": "Model Number:  ROM-5025  Lot Number:  192438    Model Number: ROM-6025  Lot Numbers:  192353, 192359, 192631"
    }
  ]
}