{
  "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": "Bridgend",
      "state": "N/A",
      "country": "United Kingdom",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "68974",
      "recalling_firm": "ORTHO-CLINICAL DIAGNOSTICS",
      "address_1": "FELINDRE MEADOWS",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "NY, NJ, CT, MA, PA, VA, MD, FL and GA",
      "recall_number": "Z-2671-2014",
      "product_description": "VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- Ortho-Clinical Diagnostics High Wycombe UK. Note that one sales unit has 5 Reagent Packs contained within it.  Each Reagent Pack can test for 100 samples (patient, Quality Control, etc.).",
      "product_quantity": "463 sales units",
      "reason_for_recall": "VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expected VITROS Anti-HCV test results due to an approximate signal loss of up to 66.2% which can result in unexpected negative test results being obtained for reactive sample fluids (quality control and patient samples).",
      "recall_initiation_date": "20140806",
      "center_classification_date": "20140919",
      "termination_date": "20170414",
      "report_date": "20141001",
      "code_info": "Lot 9090 (exp. December 15, 2014)"
    }
  ]
}