{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "183697",
      "product_res_number": "Z-0134-2021",
      "event_date_initiated": "2020-08-25",
      "event_date_posted": "2020-10-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-05-04",
      "res_event_number": "86430",
      "product_code": "CJO",
      "k_numbers": [
        "K122323"
      ],
      "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\n\nCatalog Number: K2115, SMN# 10642444",
      "code_info": "Lot Number/UDI/Exp. Date:  1) 19247AB  UDI: 0084276803903419247AB20090310642444840  Exp.2020-09-03, (2) 19282BB\t UDI: 0084276803903419282BB20100810642444840\t Exp. 2020-10-08, (3) 19330BD\t  UDI:0084276803903419330BD20112510642444840\t Exp. 2020-11-25.  Expanded Recall: 3/10/21 20337AB, 20311BA, 20275AA, 20218AA, 20203BA, 20170AA, 20125BA, 20078AB.",
      "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": "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",
      "root_cause_description": "Under Investigation by firm",
      "action": "Siemens issued Urgent Medical Device Recall (UMDC # VC-20-02.A.US via Fed'X) and Urgent Field Safety Notice (UFSN # VC-20-02.A.OUS) on August 25, 2020 to all Dimension Vista customers who received the Dimension Vista ALPI flex reagent lots 19247AB, 19282BB and 19330BD  to notify them of the issue, health risk and actions to take.  \nCustomers were instructed to:  Discontinue use of and discard the Dimension Vista ALPI lots 19247AB, 19282BB, 19330BD.\nReview their inventory of these lots to determine their laboratorys replacement needs. Complete and return the attached form to this letter to request your no-charge replacement product(s).\nComplete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days.\n\nIf they received any complaints of illness or adverse events associated with the product listed in the letter, to immediately contact their local Siemens Remote Services Center or their local Siemens Technical Support Representative.\n\nExpanded Recall 3/12/21:\nUrgent Medical Device Correction (UMDC # VC-20-02.B.US) and Urgent Field Safety Notice (UFSN # VC-20-02.B.OUS)  issued on March 12, 2021 to all Dimension Vista customers who received the Dimension Vista ALPI flex reagent lots 20337AB, 20311BA, 20275AA, 20218AA, 20203BA, 20170AA, 20125BA and 20078AB to notify them of the issue, and actions to be taken.",
      "product_quantity": "US:5970 units ; OUS: 1446 units",
      "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.",
      "openfda": {
        "k_number": [
          "K121907",
          "K982328",
          "K770155",
          "K122323"
        ],
        "device_name": "Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1050",
        "device_class": "2",
        "registration_number": [
          "2517506",
          "2432235",
          "3004493545"
        ],
        "fei_number": [
          "2517506",
          "2432235",
          "3004493545"
        ]
      }
    }
  ]
}