{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Newark",
      "state": "DE",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90669",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 Gbc Dr",
      "address_2": "",
      "postal_code": "19702-2466",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Austria, France, ¿¿ Germany, Italy, Switzerland.",
      "recall_number": "Z-1648-2022",
      "product_description": "Dimension Vista LOCI CA 15-3 Flex reagent cartridge.  In Vitro Diagnostic for the quantitative measurement of CA 15-3.   Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456",
      "product_quantity": "129 units US; 159 units OUS",
      "reason_for_recall": "Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.",
      "recall_initiation_date": "20220718",
      "center_classification_date": "20220829",
      "report_date": "20220907",
      "code_info": "UDI:   0084276802852621340BB22120610464344840,  0084276802852622049BC23021810464344840,   0084276802852622112BF23042210464344840.     Lot Numbers:   lot 21340BB   Exp Date: 2022-12-06;   lot 22049BC (corrected lot number 9/8/2022)   Exp Date: 2023-02-18;   lot 22112BF   Exp Date: 2023-04-20.",
      "more_code_info": ""
    }
  ]
}