{
  "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": "68286",
      "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 (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.",
      "recall_number": "Z-1805-2014",
      "product_description": "VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only --- VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.",
      "product_quantity": "Domestic - 464 units; Foreign - 361 units",
      "reason_for_recall": "Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator value assignment for VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739), Generation (GEN) 28.",
      "recall_initiation_date": "20140512",
      "center_classification_date": "20140616",
      "termination_date": "20170323",
      "report_date": "20140625",
      "code_info": "Lots 91131 (exp. 07-Mar-2015) and 91241 (exp. 28-Feb-2016)",
      "more_code_info": ""
    }
  ]
}