{
  "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,
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  },
  "results": [
    {
      "cfres_id": "122156",
      "product_res_number": "Z-0541-2014",
      "event_date_initiated": "2013-09-18",
      "event_date_posted": "2013-12-19",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-10-01",
      "res_event_number": "66363",
      "product_code": "LPS",
      "k_numbers": [
        "K063206"
      ],
      "product_description": "Siemens Dimension Vista Homocysteine Flex Reagent Cartridge\r\n\r\nThe HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.",
      "code_info": "lot 13064MA, expiration 2014-03-05",
      "firm_fei_number": "2517506",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 Gbc Dr Ms 514",
      "address_2": "PO BOX 6101",
      "city": "Newark",
      "state": "DE",
      "postal_code": "19702-2466",
      "additional_info_contact": "Customer Support\n800-441-9250",
      "reason_for_recall": "Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "Siemens sent a Urgent Medical Device Recall letter dated September 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers.\r\n\r\nActions  to be taken by Customer:\r\n\r\nPlease discontinue use and discard any remaining inventory of Dimension Vista HCYS Flex reagent cartridge (Catalog# K7044) lot 13064MA.\r\n\r\nPlease complete the attached form and fax it to (302) 631-8467 to facilitate your no charge replacement needs.\r\n\r\nPlease retain this letter with your laboratory records, and forward this letter to those who may have received this product.\r\n\r\nWe apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Customer Care Center- Technical Solutions or your local Siemens technical support representative. \r\n\r\nFor further questions please call (800) 441-9250.",
      "product_quantity": "302",
      "distribution_pattern": "Worldwide Distribution - US Distribution including the states of OH, MD, CO, NJ, IA, NC, VA, WI and DC., and the countries of Austria, Denmark, France, Italy, Netherlands and Norway.",
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        "device_name": "Urinary Homocystine (Nonquantitative) Test System",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1377",
        "device_class": "2"
      }
    }
  ]
}