{
  "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": [
    {
      "country": "United States",
      "city": "Rochester",
      "address_1": "100 Indigo Creek Dr",
      "reason_for_recall": "While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of surfactant was unintentionally added to VITROS Chemistry Products CRP Slides during the manufacturing process.",
      "address_2": "",
      "product_quantity": "Domestic: 4,257; Foreign: 923",
      "code_info": "GEN 3773, Coating 0766, Lot XXXX (exp. 11/01/2013); GEN 3784, Coating 0767, Lot XXXX (exp. 11/01/2013); and GEN 3785, Coating 0768, Lot XXXX (exp. 10/01/2013 and 11/01/2013).  The term GEN and Coating refer to specific segments of the reagent lot number.",
      "center_classification_date": "20130627",
      "distribution_pattern": "Worldwide Disribution - USA Nationwide including Puerto Rico, and  the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico,  Republic of Panama, Singapore, Spain and Venezuela.",
      "state": "NY",
      "product_description": "VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990,     Product Usage:  For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.",
      "report_date": "20130703",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "recall_number": "Z-1615-2013",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "65247",
      "termination_date": "20150612",
      "more_code_info": "",
      "recall_initiation_date": "20130509",
      "postal_code": "14626-5101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}