{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "196103",
      "product_res_number": "Z-0089-2023",
      "event_date_initiated": "2022-08-24",
      "event_date_posted": "2022-10-14",
      "recall_status": "Open, Classified",
      "res_event_number": "90872",
      "product_code": "JHM",
      "k_numbers": [
        "K081300"
      ],
      "product_description": "Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD\nSiemens Material Number (SMN): 10464340\t\nCatalog Number: K3048A",
      "code_info": "UDI-DI : 0084276802043821250BA2022090710464340840\nLot Number: 21250BA\nExp. Date: 2022-09-07",
      "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": "Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an  Abnormal Reaction  [E145]: flag, a falsely depressed or elevated result ranging from -90% to 133% may be observed.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Siemens issued an Urgent Medical Device Correction (UMDC) mailed to  US affected customers by FedEx beginning on 08/24/2022. \tAn Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities beginning on 08/24/2022.\n\nLetter states:\n Discontinue use of and discard the lot listed in Table 1.\n Review your inventory of this lot to determine your laboratory s replacement needs and to provide information to Siemens for reporting to the Authorities.\nPlease review this letter with your Medical Director.\nComplete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days to Siemens Healthineers for reporting to the Authorities.\n If you have received any complaints of illness or adverse events associated with the\nproducts listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers Technical Support Representative.\nPlease retain this letter with your laboratory records and forward this letter to those who may have received this product.\n If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers Technical Support Representative.",
      "product_quantity": "1592 units",
      "distribution_pattern": "Nationwide\nForeign: Canada",
      "openfda": {
        "k_number": [
          "K780173",
          "K841056",
          "K983849",
          "K032798",
          "K022519",
          "K902935",
          "K120662",
          "K081300",
          "K073072"
        ],
        "registration_number": [
          "",
          "2517506",
          "3010825766",
          "3014325803",
          "1181055"
        ],
        "fei_number": [
          "",
          "2517506",
          "3010825766",
          "3014325803",
          "1181055"
        ],
        "device_name": "Colorimetric Method, Lipoproteins",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1475",
        "device_class": "1"
      }
    }
  ]
}