{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Newark",
      "address_1": "500 Gbc Dr Ms 514",
      "reason_for_recall": "A positive bias beyond 5% resulting in a dilution check failure or an unnecessary dilution check correction if the positive bias is greater than 1% and less than 5%. The dilution check correction would be detected by QC; however, if not detected by QC, the calibration curve would be decreased and cause elevated sodium, potassium and chloride patient results.",
      "address_2": "PO BOX 6101",
      "product_quantity": "5981",
      "code_info": "Catalog Number S640, Siemens Material Number (SMN) 10444872, Lot Number 4MD707",
      "center_classification_date": "20150407",
      "distribution_pattern": "Worldwide Distribution.",
      "state": "DE",
      "product_description": "QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module.   Intended Use of the QuikLYTE module : The Na+, K+, Cl and TCO2 methods on the Dimension clinical chemistry system with the QuikLYTE module are in vitro diagnostic tests intended for the quantitative measurement of sodium, potassium, chloride and total carbon dioxide in human serum and heparinized plasma. They are also intended for the quantitative measurement of Na+, K+ and Cl- in urine.",
      "report_date": "20150415",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "recall_number": "Z-1398-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "70627",
      "termination_date": "20170201",
      "recall_initiation_date": "20150224",
      "postal_code": "19702-2466",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}