{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "198493",
      "product_res_number": "Z-1258-2023",
      "event_date_initiated": "2023-01-30",
      "event_date_posted": "2023-03-15",
      "recall_status": "Open, Classified",
      "res_event_number": "91677",
      "product_code": "MLM",
      "k_numbers": [
        "K150168"
      ],
      "product_description": "Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension clinical chemistry system\nSMN: 10700795 (DF207)",
      "code_info": "UDI:\n00842768035425GA228622101310700795840,\n00842768035425GA304723021610700795840,\n00842768035425GA317123062010700795840.\nLot Numbers:\nGA2286, GA3047, GA3171",
      "firm_fei_number": "2432235",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "511 Benedict Ave",
      "city": "Tarrytown",
      "state": "NY",
      "postal_code": "10591-5005",
      "additional_info_contact": "SAME\n914-631-8000",
      "reason_for_recall": "Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lots GA2286, GA3047 and GA3171. The health consequences of erroneous patient results are major, since in a worst case scenario, a patient s tacrolimus dosing could be altered, resulting in potential organ failure and rejection (due to too low or no tacrolimus being administered) or toxicity (due to too much tacrolimus being administered). Siemens internal investigation of the Dimension TAC assay showed the worst case imprecision with patient samples at the low end of the Analytical Measurement Range (AMR). A patient sample at 2.0 ng/mL (2.6 nmol/L) recovered as 0.0 ng/mL (0.0 nmol/L) (100% negative bias), another patient sample at 2.1 ng/mL (2.7 nmol/L) recovered at 4.3 ng/mL (5.6 nmol/L)  (103% positive bias).",
      "root_cause_description": "Under Investigation by firm",
      "action": "Siemens issued to US Customers Urgent Medical Device Correction (DC-23-03.A.US)\nvia FedEx beginning on 01/30/2023.  OUS Customers sent Urgent Field Safety Notice (DC-23-03.A.OUS). Letter states reason for recall, health risk and action to take:\n\nDiscontinue use and discard the lots listed in Table 1 and complete the attached\nProduct Replacement form for no-charge product replacement. Please note, lot\nGA2286 is expired.\nReview your inventory to determine possible replacement needs and provide\ninformation to Siemens for reporting to the Authorities.\n Please review this letter with your Medical Director and the decision on a review of\npreviously generated results.\n If you receive any complaints of illness or adverse events associated with the products\nlisted in Table 1, immediately contact your local Siemens Remote Services Center or\nyour local Siemens Technical Support Representative.\n Complete and return the Field Correction Effectiveness Check/Product Replacement\nForm attached to this letter within 30 days to Siemens Healthineers for reporting to the\nAuthorities.\nQuestions, contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers Technical Support Representative.",
      "product_quantity": "6035 units",
      "distribution_pattern": "Worldwide and Nationwide Distribution\nForeign:\nAregentina\nBrazil\nChile\nColombia\nCountry\nIndia\nJapan\nNew Zealand\nNicaragua\nSaudi¿Arabia¿¿¿\nSouth Africa\nSouth Korea\nSpain¿¿¿¿¿¿¿¿¿¿\nSri Lanka\nTaiwan",
      "openfda": {
        "k_number": [
          "K060385",
          "K063868",
          "K060502",
          "K203833",
          "K050206",
          "K150168",
          "K173857",
          "K070820",
          "K123343"
        ],
        "pma_number": [
          "P970007",
          "P970025"
        ],
        "registration_number": [
          "3005333358",
          "3003951180",
          "2521625",
          "3008344661",
          "9610126",
          "9616673",
          "3026848661",
          "1643621",
          "2517506",
          "2432235",
          "3010939897",
          "1415939",
          "1218959"
        ],
        "fei_number": [
          "3005333358",
          "3003179344",
          "3003951180",
          "2521625",
          "3008344661",
          "3026848661",
          "1643621",
          "2517506",
          "2432235",
          "3010939897",
          "1415939",
          "3002806559",
          "1218959"
        ],
        "device_name": "Enzyme Immunoassay, Tracrolimus",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1678",
        "device_class": "2"
      }
    }
  ]
}