{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "211284",
      "product_res_number": "Z-0727-2025",
      "event_date_initiated": "2024-11-18",
      "event_date_posted": "2024-12-20",
      "recall_status": "Open, Classified",
      "res_event_number": "95816",
      "product_code": "MMI",
      "k_numbers": [
        "K121214",
        "K172783",
        "K222881",
        "K230648"
      ],
      "product_description": "Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit.\nFor the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.",
      "code_info": "UDI/DI 15099590693183, All Lots",
      "firm_fei_number": "2122870",
      "recalling_firm": "Beckman Coulter, Inc.",
      "address_1": "1000 Lake Hazeltine Dr",
      "city": "Chaska",
      "state": "MN",
      "postal_code": "55318-1037",
      "additional_info_contact": "Ian Pilcher\n952-448-4848",
      "reason_for_recall": "Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The reason for the recall is: high troponin antigen (>55,000 pg/mL) can contaminate an analyzers probe and cause inter-assay carryover due to insufficient washing. The contamination can cause a falsely elevated Access hsTnI result in subsequent sample(s) which can impact patient care (potentially but not limited to unnecessary coronary imaging or diagnostic catheterization) if the result is near the medical decision points.",
      "root_cause_description": "Component design/selection",
      "action": "Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 11/18/2024 via USPS and email.  The notice explained the issue, impact to patient care, and requested the following actions be taken:  \n\" - Follow your established laboratory protocols for analyzing and retesting discrepant samples if an observed Access hsTnI test result does not align with the patient s clinical presentation.\n - Beckman Coulter recommends reviewing the content of this letter with your laboratory and/or medical director to determine appropriate next steps.\nPlease share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded the affected product listed above to another laboratory, please provide them a copy of this letter.\"",
      "product_quantity": "2,109,804 units",
      "distribution_pattern": "Worldwide",
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        "device_name": "Immunoassay Method, Troponin Subunit",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1215",
        "device_class": "2"
      }
    }
  ]
}