{
  "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": "86374",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 Gbc Dr",
      "address_2": "N/A",
      "postal_code": "19702-2466",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-0052-2021",
      "product_description": "Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the  quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068",
      "product_quantity": "533 US and 1822 OUS",
      "reason_for_recall": "Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for  patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile observed",
      "recall_initiation_date": "20200819",
      "center_classification_date": "20201002",
      "termination_date": "20230825",
      "report_date": "20201014",
      "code_info": "Lot # EB0255 UDI: 00842768037726EB025520091110471068840"
    }
  ]
}