{
  "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": "Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS Chemistry Products Specialty Diluent (Lot F3168) or VITROS Chemistry Products FS Diluent Pack 3 (Lot 01-3266).  The VITROS Instructions for Use states that if the if a C-reactive protein concentration exceeds the systems measuring (reportable or dynamic) range, dilute the sample with VITROS Specialty Diluent or a patient sample containing a low concentration of CRP. An initial threefold dilution is recommended. Internal testing determined that results using VITROS CRP Slides have the potential for approximately 51% bias using a 3x dilution factor.",
      "address_2": "",
      "product_quantity": "1656 distributed (1200 went to warehouse in France)",
      "code_info": "Lot F3168 (exp. 30 Sep 2014)",
      "center_classification_date": "20140428",
      "distribution_pattern": "Nationwide, Puerto Rico, and foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico,  Panama, Singapore, Spain and Venezuela.",
      "state": "NY",
      "product_description": "VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY",
      "report_date": "20140507",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "recall_number": "Z-1519-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "67883",
      "termination_date": "20170327",
      "more_code_info": "",
      "recall_initiation_date": "20140326",
      "postal_code": "14626-5101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}