{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "183505",
      "product_res_number": "Z-0052-2021",
      "event_date_initiated": "2020-08-19",
      "event_date_created": "2020-10-02",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-08-25",
      "res_event_number": "86374",
      "product_code": "MMI",
      "k_numbers": [
        "K190675"
      ],
      "product_description": "Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the\nquantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068",
      "code_info": "Lot # EB0255 UDI: 00842768037726EB025520091110471068840",
      "firm_fei_number": "2517506",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 Gbc Dr",
      "city": "Newark",
      "state": "DE",
      "postal_code": "19702-2466",
      "additional_info_contact": "SAME\n800-441-9250",
      "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\npatient 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",
      "root_cause_description": "Under Investigation by firm",
      "action": "Siemens issued Urgent Medical Device Correction (UMDC # VC-20-03.B.US) and Urgent Field Safety Notice (UFSN # VC-20-03.B.OUS)  issued on August 19, 2020 via FedX to US Dimension customers who received the Dimension TNIH reagent lot to notify them of the issue, the risk to health, and the following actions to be taken by the customer:\nReview the letter with their Medical Director\"If they are using TNIH lot EB0255 DO NOT switch to another TNIH lot during serial measurements for a single patient sample.\nDiscontinue use and discard the TNIH reagent lot EB0255 upon receipt of replacement product.\nRequest your no-charge replacement for lot EB0255.\nComplete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days.\nQuestions, contact your Siemens Remote Services Center or your local Siemens Technical Support representative.",
      "product_quantity": "533 US and 1822 OUS",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
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        "device_name": "Immunoassay Method, Troponin Subunit",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1215",
        "device_class": "2"
      }
    }
  ]
}