{
  "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": "San Jose",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87049",
      "recalling_firm": "VISBY MEDICAL INC",
      "address_1": "3010 N 1st St",
      "address_2": "N/A",
      "postal_code": "95134-2023",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "U.S. Nationwide distribution including in the states of CA, DC, FL, GA, MD, MN, MT, VA, and WA. O.U.S.: None",
      "recall_number": "Z-0847-2021",
      "product_description": "visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19 Test is only for use under the Food and Drug Administration s Emergency Use Authorization.",
      "product_quantity": "Total = 282 kits",
      "reason_for_recall": "Two issues:  1) 5 Lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived.  2) 3 Lots contain a kit component that expires prior to the expiration date on the test kits.",
      "recall_initiation_date": "20201205",
      "center_classification_date": "20210112",
      "termination_date": "20220107",
      "report_date": "20210120",
      "code_info": "Part Number: PS-001442  Lot Numbers:  LN20100067  LN20100148  LN20110040  LN20110213  WR20100003    Emergency Use Authorization (EUA202677)"
    }
  ]
}