{
  "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": "Newark",
      "state": "DE",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81433",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 Gbc Dr Ms 514",
      "address_2": "N/A",
      "postal_code": "19702-2466",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide-domestic nationwide and foreign distribution.",
      "recall_number": "Z-0499-2019",
      "product_description": "Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista¿ System.Cat. No. K2054, Mat. No. 10464323",
      "product_quantity": "13435",
      "reason_for_recall": "Siemens Healthcare Diagnostics has confirmed that Dimension Vista Lactate Dehydrogenase  (LDI) may exhibit an erroneously elevated result when the preceding assay in the reaction  cuvette is Lactic Acid (LA). The magnitude of the elevation may be variable. Both quality control  and patient samples may be impacted. Incomplete removal of residual lactate dehydrogenase, a  component of the LA reagent, has been identified as the cause of the potentially elevated result. A falsely elevated result for lactate dehydrogenase may lead to additional investigations to  determine the etiology of tissue damage. Results would be correlated with clinical history and  presentation in addition to other diagnostic laboratory testing.",
      "recall_initiation_date": "20181011",
      "center_classification_date": "20181127",
      "termination_date": "20200629",
      "report_date": "20181205",
      "code_info": "18240BA  18199BA  18162AC  18155BB  18106BC  18073BE  18036BC  17342BA"
    }
  ]
}