{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Rochester",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "94734",
      "recalling_firm": "Ortho-Clinical Diagnostics, Inc.",
      "address_1": "100 Indigo Creek Dr",
      "address_2": "N/A",
      "postal_code": "14626-5101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France,  Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.",
      "recall_number": "Z-2245-2024",
      "product_description": "VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent  Model/Catalog Number: 6802344",
      "product_quantity": "1718",
      "reason_for_recall": "Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024.  If used past its true expiration and the customer does not have their Assay Data Disk (ADD) updated, the system will allow them to use the expired calibrator which may bias the results. However, at this time the calibrator is within its use date and will function appropriately.",
      "recall_initiation_date": "20240514",
      "center_classification_date": "20240701",
      "report_date": "20240710",
      "code_info": "(UDI/GTIN# 10758750002672;  Lot Number 2953; Expiration Date: 24-Jul-2024"
    }
  ]
}