{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bridgend",
      "state": "",
      "country": "United Kingdom",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "74346",
      "recalling_firm": "ORTHO-CLINICAL DIAGNOSTICS",
      "address_1": "FELINDRE MEADOWS",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "US Nationwide Distribution",
      "recall_number": "Z-2145-2016",
      "product_description": "VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were included in the communication because they are lot-linked to the Reagent Packs and cannot be used with any other lot of reagent. There is no known failure with the Calibrators.     For the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the management of patients with non-seminomatous testicular cancer.",
      "product_quantity": "US: Lot 6471 - 282, Lot 6480 - 344",
      "reason_for_recall": "Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the reaction signal over time potentially resulting in the inability to calibrate and use the product.",
      "recall_initiation_date": "20160509",
      "center_classification_date": "20160708",
      "termination_date": "20180608",
      "report_date": "20160720",
      "code_info": "Lots 6471 (expiry date 19-Jul-2016), 6480 (expiry date 23-Aug-2016)",
      "more_code_info": ""
    }
  ]
}