{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Raritan",
      "address_1": "1001 US Highway 202",
      "reason_for_recall": "Potential for Negatively Biased Na+ Urine Results Using  Several Lots of VITROS Chemistry Products Calibrator Kit 2",
      "address_2": "",
      "product_quantity": "39709 units (12734 US and 26975 OUS)",
      "code_info": "Lot #  /Exp. Date:  Lot 277 11-Dec-2019;  Lot 288 31-May-2020;  Lot 298 12-Nov-2020;  Lot 219 15-Jul-2021.    UDI: 10758750009503",
      "center_classification_date": "20200213",
      "distribution_pattern": "Nationwide  Foreign:  Australia  Brazil  Canada L3R 4G5   Chile  China  Colombia  India  Japan  Mexico  Singapore   United Kingdom  France  Germany  Italy  Spain  Portugal  Poland  Russia  Denmark  Norway  Sweden  Belgium  Netherlands",
      "state": "NJ",
      "product_description": "VITROS Chemistry Products Calibrator Kit 2- IVD  calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG  Product Code: 1662659",
      "report_date": "20200219",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Ortho Clinical Diagnostics Inc",
      "recall_number": "Z-1226-2020",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "84654",
      "termination_date": "20201112",
      "more_code_info": "",
      "recall_initiation_date": "20191216",
      "postal_code": "08869-1424",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}