{
  "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": "149026",
      "product_res_number": "Z-0039-2017",
      "event_date_initiated": "2016-08-03",
      "event_date_posted": "2016-10-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-05-11",
      "res_event_number": "74987",
      "product_code": "CIC",
      "k_numbers": [
        "K061792"
      ],
      "product_description": "Dimension Vista Calcium (CA) Flex reagent cartridge\nDevice Listing No.:  D011443\nBatch Number: 16060BB",
      "code_info": "Device Listing No: D011443 Batch Number 16060BB",
      "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": "800-441-9250",
      "reason_for_recall": "Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Siemens mailed on August 09, 2016, an Urgent Medical Device Recall letter to all customers who purchased the CA lot 16060BB.  The notification letter requested that customers discontinue use and discard the affected kit.",
      "product_quantity": "5,991 cartridges",
      "distribution_pattern": "Distributed Nationwide and the countries of : Austria, Bahamas, Belgium, Canada, Czech Republic, Denmark, Germany, Italy, Japan, Netherlands, Portugal, Saudi Arabia, South Korea, Slovenia, and Spain.",
      "openfda": {
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        "device_name": "Cresolphthalein Complexone, Calcium",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1145",
        "device_class": "2"
      }
    }
  ]
}