{
  "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": "36135",
      "product_res_number": "Z-0387-05",
      "event_date_initiated": "2004-11-22",
      "event_date_posted": "2005-01-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-05-02",
      "res_event_number": "30570",
      "product_code": "DCK",
      "k_numbers": [
        "K030626"
      ],
      "product_description": "Vitros CRP (C-Reactive Protein) Slides.  Catalog #192 6740 contains 250 slides; Catalog #809 7990 contains 90 slides.  Firm on label:  Ortho-Clinical Diagnostics, a Johnson & Johnson Company, Rochester, NY  14626.",
      "code_info": "Coatings 401 thru 419.",
      "firm_fei_number": "1000136573",
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "address_1": "100 Indigo Creek Dr",
      "city": "Rochester",
      "state": "NY",
      "postal_code": "14626-5101",
      "additional_info_contact": "Sherry L. Phillips\n585-453-3728",
      "reason_for_recall": "Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range.",
      "root_cause_description": "Other",
      "action": "Letters dated 11/22/2004 issued to customers.  End users instructed to manually modify the Reportable and/or Analyzer Ranges; dilute all samples with an initial CRP result greater than 9.0 mg/dL.  Distributors instructed to destroy product in-house and to notify end-users to manually modify the Reportable and/or Analyzer Ranges.",
      "product_quantity": "Cat. 1926740 - 20,903 boxes; Cat 8097990 - 34,877 boxes",
      "distribution_pattern": "Nationwide and worldwide distribution.  70% of product was shipped to foreign consignees.",
      "openfda": {
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        "device_name": "C-Reactive Protein, Antigen, Antiserum, And Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5270",
        "device_class": "2"
      }
    }
  ]
}