{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "117800",
      "product_res_number": "Z-0517-2014",
      "event_date_initiated": "2013-04-25",
      "event_date_posted": "2013-12-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-11-12",
      "res_event_number": "65051",
      "product_code": "MLM",
      "product_description": "Dimension(R) TACR Flex(R) reagent cartridge (DF107)\n\nThe TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of Tacrolimus therapy in kidney and liver transplant patients",
      "code_info": "Siemens Material Number 10444938, lot numbers GB3099, GA3120, DB3141, GB3162, GB3176, FA3197, FA3267 and FB3267.",
      "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": "Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results.",
      "root_cause_description": "Component design/selection",
      "action": "Siemens sent an Urgent Medical Device Correction letter dated April 2013, to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.  A recall notification letter was sent to consignees in April 2013.  Customers using the affected product should load Flex reagent cartridges on board immediately prior to use and remove the Flex after 8 hours.  Do not load more Flexes than the lab will use in 8 hours and do not pre-hydrate TACR Flexes.  Customers were asked to complete the attached Effectiveness Check form and fax it to the Siemens Technical Solutions Center at 302-631-8467.  Customers were asked to forward the communication to anyone to whom may have distributed the product.  Customers with questions were instructed to contact the Siemens Technical Solutions Center or their local Siemens technial support representative.  For questions regarding this recall call 800-441-9250.",
      "product_quantity": "13,751",
      "distribution_pattern": "Nationwide Distribution including AK, AL, AR, AZ, CA, DC, FL, GA, IA, IL, LA, MD, MI, MO, MS, NC, NH, NJ, NM, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA,  and WI.",
      "openfda": {
        "k_number": [
          "K060385",
          "K063868",
          "K203833",
          "K070820",
          "K173857",
          "K050206",
          "K060502",
          "K150168",
          "K123343"
        ],
        "pma_number": [
          "P970007",
          "P970025"
        ],
        "registration_number": [
          "3026848661",
          "2432235",
          "2517506",
          "1415939",
          "9610126",
          "1643621",
          "2521625",
          "9616673",
          "3008344661",
          "3005333358",
          "1218959",
          "3010939897",
          "3003951180"
        ],
        "fei_number": [
          "1218959",
          "3026848661",
          "2432235",
          "2517506",
          "1415939",
          "1643621",
          "2521625",
          "3008344661",
          "3005333358",
          "3003179344",
          "3010939897",
          "3002806559",
          "3003951180"
        ],
        "device_name": "Enzyme Immunoassay, Tracrolimus",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1678",
        "device_class": "2"
      }
    }
  ]
}