{
  "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": [
    {
      "status": "Terminated",
      "city": "Rochester",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "68840",
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "address_1": "1000 Lee Road",
      "address_2": "N/A",
      "postal_code": "14606",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA including MA, TX, KY, IL, MS, OH and Puerto Rico; Internationally to: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.",
      "recall_number": "Z-2214-2014",
      "product_description": "VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS¿ Chemistry Products DT Calibrator Kit  lot 44 (Product Code 1957927) and tested on the VITROS DT60/DT60 II Chemistry System: IVD, Made in USA by Ortho-Clinical Diagnostics, Inc. Rochester, NY",
      "product_quantity": "5906 total: 240 (US); 5666 (OUS)",
      "reason_for_recall": "Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Calibrator Kit, Lot 44 when CDM PROM 0168 or 0169 is installed on VITROS DT60/DT60 II Chemistry Systems.",
      "recall_initiation_date": "20140715",
      "center_classification_date": "20140814",
      "termination_date": "20180521",
      "report_date": "20140820",
      "code_info": "Lots 0168 and 0169"
    }
  ]
}