{
  "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": "Lombard",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88477",
      "recalling_firm": "Thera Test Laboratories, Inc.",
      "address_1": "1120 N Du Page Ave",
      "address_2": "N/A",
      "postal_code": "60148-1247",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of CA, FL, IL, IN, NC, and TX.",
      "recall_number": "Z-2381-2021",
      "product_description": "EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129",
      "product_quantity": "11 kits",
      "reason_for_recall": "Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129",
      "recall_initiation_date": "20200730",
      "center_classification_date": "20210827",
      "termination_date": "20220215",
      "report_date": "20210908",
      "code_info": "Kit lot numbers 05204350, exp. 05/01/2021; 05204367, exp. 05/19/2021; and 06204432, exp. 05/19/2021."
    }
  ]
}