{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Roswell",
      "state": "GA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88344",
      "recalling_firm": "OPTI Medical Systems, Inc",
      "address_1": "235 Hembree Park Dr",
      "address_2": "N/A",
      "postal_code": "30076-5738",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Maine, New York, Alabama, Pennsylvania, Florida, Illinois, New Jersey, Connecticut, Georgia, Puerto Rico, Costa Rica, Hong Kong, Philippines, Barbados",
      "recall_number": "Z-2310-2021",
      "product_description": "OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003  b) 99-57004",
      "product_quantity": "3552 kits",
      "reason_for_recall": "The firm identified a precipitation issue which may cause late Ct reactors (a false positive result) with a rate of 5 to 10% for affected vials of RNA Master Mix.",
      "recall_initiation_date": "20210625",
      "center_classification_date": "20210817",
      "report_date": "20210825",
      "code_info": "a) 99-57003, Lot Numbers: 20808, 20812, 20813 b) 99-57004, Lot Numbers: 20881, 20901, 211013"
    }
  ]
}