{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Newark",
      "state": "DE",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86430",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 Gbc Dr",
      "address_2": "N/A",
      "postal_code": "19702-2466",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Australia, Austria, Belgium, Bahamas, Czech Republic, Denmark, France, Germany, Italy, Japan, Korea, Netherlands, Norway, New Zealand, Portugal, Slovakia, Slovenia, Spain, Switzerland.",
      "recall_number": "Z-0134-2021",
      "product_description": "Siemens Dimension Vista  Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma    Catalog Number: K2115, SMN# 10642444",
      "product_quantity": "US:5970 units ; OUS: 1446 units",
      "reason_for_recall": "Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately -27% at a concentration of 129 U/L (2.15 ukat/L).  The low outlier results are generated from the last five (5) tests of the well",
      "recall_initiation_date": "20200825",
      "center_classification_date": "20201020",
      "termination_date": "20230504",
      "report_date": "20201028",
      "code_info": "Lot Number/UDI/Exp. Date:    1) 19247AB   UDI: 0084276803903419247AB20090310642444840   Exp.2020-09-03,  (2) 19282BB   UDI: 0084276803903419282BB20100810642444840   Exp. 2020-10-08,  (3) 19330BD    UDI:0084276803903419330BD20112510642444840   Exp. 2020-11-25.    Expanded Recall: 3/10/21  20337AB, 20311BA, 20275AA, 20218AA, 20203BA, 20170AA, 20125BA, 20078AB."
    }
  ]
}