{
  "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": "Brea",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88612",
      "recalling_firm": "Beckman Coulter Inc.",
      "address_1": "250 S Kraemer Blvd",
      "address_2": "",
      "postal_code": "92821-6232",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide distribution in the states of AZ, CA, GA, IL, IA, KY, MI, NJ, NY, NC, OH, PA, Puerto Rico, TN, TX, VA, and WA.",
      "recall_number": "Z-2508-2021",
      "product_description": "Access SARS CoV-2 IgG (1st IS) Assay:    Access Immunoassay Systems REAGENT PACK, REF C74339    Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340    Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341",
      "product_quantity": "303 kits (U.S.) and 964 kits (O.U.S.)",
      "reason_for_recall": "Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute",
      "recall_initiation_date": "20210805",
      "center_classification_date": "20210922",
      "termination_date": "20230601",
      "report_date": "20210929",
      "code_info": "Part Number: C74339 UDI Code: (01)15099590746919(17)210930(11)210402(10)124466 Lot Number:  124466;  Part Number:  C74340 UDI Codes: (01)15099590746926(17)210930(11)210402(10)124467; (01)15099590746926(17)211231(11)210703(10)124758; Lot Numbers: 124467; 124758;  Part Number: C74341 UDI Codes: (01)15099590746933(17)210930(11)210402(10)124468; (01)15099590746933(17)211130(11)210602(10)124708; Lot Numbers: 124468; 124708;",
      "more_code_info": ""
    }
  ]
}