{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Newark",
      "address_1": "500 Gbc Dr Ms 514",
      "reason_for_recall": "The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing separation between the Level 1 and Level 2 calibrators. The negative bias observed for patient, QC, and calibrator samples, when using any of the listed lots, has the potential to impact the interpretation of gentamicin results during therapeutic monitoring at concentrations up to approximately 2.5 ¿g/mL [5.4 ¿mol/L].",
      "address_2": "Po Box 6101",
      "product_quantity": "20373",
      "code_info": "Lots 17135BC  17150BF  17159BD  17178AC  17269BD  17312BB",
      "center_classification_date": "20180613",
      "distribution_pattern": "Nationwide distribution. Foreign distribution to Argentina, Australia, Brazil, Bahamas, Canada, Germany, India, Japan, Myanmar, New Zealand, Saudi Arabia, Taiwan, and South Africa.",
      "state": "DE",
      "product_description": "Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay.  Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and  17312BB.",
      "report_date": "20180620",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "recall_number": "Z-2182-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "80009",
      "termination_date": "20200424",
      "recall_initiation_date": "20180419",
      "postal_code": "19702-2466",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}