{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "30737",
      "product_res_number": "Z-0299-04",
      "event_date_initiated": "2003-12-03",
      "event_date_posted": "2004-01-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-02-20",
      "res_event_number": "27915",
      "product_code": "DHX",
      "product_description": "Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack.  Firm on the label:  Ortho-Clinical Diagnostics, Amersham, UK.",
      "code_info": "Lot #750, Exp. 14 January 2004",
      "firm_fei_number": "1000136573",
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "address_1": "100 Indigo Creek Drive",
      "city": "Rochester",
      "state": "NY",
      "postal_code": "14650-0881",
      "additional_info_contact": "Sherry L. Phillips\n585-453-3728",
      "reason_for_recall": "Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.",
      "root_cause_description": "Other",
      "action": "U.S. customers notified via FED EX letter sent on 12/3/03.  Letter includes modified QC procedures to use until replacement product is issued.  Foreign affiliates notified via e-mail on 12/3/03 with instructions to notify customers.",
      "product_quantity": "524 reagent packs",
      "distribution_pattern": "154 reagent packs shipped to consignees in the U.S.  370 reagent packs shipped to Ortho/J&J International Affiliates for further distribution to foreign users.  Foreign consignees are located in Argentina, Australia, Belgium, Brazil, Chile, China, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Portugal, Puerto Rico, Singapore, Spain, United Kingdom, and Venezuela.",
      "openfda": {
        "k_number": [
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          "K200215",
          "K023893",
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          "K991707",
          "K924857",
          "K080194",
          "K013568",
          "K990774",
          "K980887",
          "K970877",
          "K810459",
          "K081615",
          "K801306",
          "K833318",
          "K981985",
          "K820298",
          "K812658"
        ],
        "pma_number": [
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          "P830066",
          "P920021",
          "P800063",
          "P860058",
          "P800005",
          "P840019",
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        "registration_number": [
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          "2517506",
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          "3006198300",
          "3002806559",
          "1000306617"
        ],
        "device_name": "System, Test, Carcinoembryonic Antigen",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.6010",
        "device_class": "2"
      }
    }
  ]
}