{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Newark",
      "address_1": "500 Gbc Dr Ms 514",
      "reason_for_recall": "Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its linked calibrator (DC 107) lot 3BD029. Falsely low Tacrolimus results across the assay range may lead to alterations in dosing.",
      "address_2": "PO BOX 6101",
      "product_quantity": "5423",
      "code_info": "TACR Flex Reagent cartridge, material #10444938, (DF107) lot BB4087 with expiration date 3/28/14 and its linked calibrator, material #10445012, (DC 107) lot 3BD029 with expiration date 03/01/14.",
      "center_classification_date": "20130807",
      "distribution_pattern": "USA Nationwide Distribution including the states of:  TX, NC, GA, TN, UT, NJ, MI, VA, AR, LA, MO, FL, AZ, CA, DC, PA, NH, WI, SD, SC, NM, MD, and IN.",
      "state": "DE",
      "product_description": "Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107)    Product Usage:  The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of tacrolimus therapy in kidney and liver transplant patients.",
      "report_date": "20130814",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "recall_number": "Z-1924-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "65706",
      "termination_date": "20140826",
      "recall_initiation_date": "20130701",
      "postal_code": "19702-2466",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}