{
  "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": "167891",
      "product_res_number": "Z-0466-2019",
      "event_date_initiated": "2018-09-07",
      "event_date_created": "2018-11-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-11-16",
      "res_event_number": "81237",
      "product_code": "CHI",
      "k_numbers": [
        "K952816"
      ],
      "product_description": "Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745\n\nProduct Usage:\nDimension Vista - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension Vista System.",
      "code_info": "Lot Numbers:  18128BA, 18172BA, 18186BB",
      "firm_fei_number": "2517506",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 Gbc Dr Ms 514",
      "city": "Newark",
      "state": "DE",
      "postal_code": "19702-2466",
      "additional_info_contact": "Heydi Calderon\n302-631-0522",
      "reason_for_recall": "There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Urgent Medical Device Correction letters dated 9/7/18 were distributed to customers. The letter identified the affected product, problem and actions to be taken.  Customers were instructed to complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days.\nPlease retain this letter with your laboratory records, and forward this letter to those who may have received this product.",
      "product_quantity": "3956",
      "distribution_pattern": "Worldwide - US Nationwide  Distributions\n\nThe products were distributed to the following foreign countries:  Argentina, Australia, Bangladesh, Brazil, Canada, Chile, China, Colombia, Germany, Ecuador, Honduras, Indonesia, India, Japan, Republic of Korea, Mexico, Malaysia, Nicaragua, New Zealand, Peru, Philippines, Paraguay, El Salvador, Thailand, Taiwan, Uruguay and South Africa, Austria, Bahamas, Belgium, Czech Republic, Denmark, , France, , Italy, Netherland, Norway , Portugal, Kuwait, Slovenia, Spain, Switzerland, United Kingdom, Qatar,  Republic of Korea, Saudi Arabia, Slovakia, Algeria, Bahrain, Bulgaria, Egypt, , Hungary, Latvia, Lebanon, Lithuania, Macedonia, Nepal, Poland, Romania, Russia Fed, Serbia, Turkey, U.A.E, United Kingdom.",
      "openfda": {
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        "fei_number": [
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        ],
        "device_name": "Lipase-Esterase, Enzymatic, Photometric, Lipase",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1465",
        "device_class": "1"
      }
    }
  ]
}