{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "30671",
      "product_res_number": "Z-0296-04",
      "event_date_initiated": "2003-12-03",
      "event_date_posted": "2004-01-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-04-20",
      "res_event_number": "27874",
      "product_code": "DCK",
      "k_numbers": [
        "K001009"
      ],
      "product_description": "POLYMEDCO ULTRA-CRP LATEX ENHANCED ASSAY, Catalog No. CPU400. Contents: 1 x 50 ML R1, 2 x 6 ML R2.   R1 is the HIGH SENSITIVE CRP Buffer IVD (50 ml). R2 is the HIGH SENSITIVE CRP Latex IVD (6 ml). For In Vitro Diagnostic (IVD) use only.\n\nCOMMON/USUAL NAME: High-Sensitive C-Reactive Protein --- CLASSIFICATION NAME: C-reactive Protein, Antigen, Antiserum",
      "code_info": "Lot numbers 1155J (EXP. 09/04) and 1388J (EXP. 10/04)",
      "firm_fei_number": "1000119795",
      "recalling_firm": "Polymedco, Inc",
      "address_1": "510 Furnace Dock Road",
      "city": "Cortlandt Manor",
      "state": "NY",
      "postal_code": "10567-6220",
      "additional_info_contact": "Ms. Helen Landicho\n914-739-5400",
      "reason_for_recall": "Firm was notified by the foreign manufacturer that certain lots of Ultra-CRP are prone to prozone (a condition of antibody antigen excess) and do not meet the labeled specifications.",
      "root_cause_description": "Other",
      "action": "By phone on 12/3/03 and by mail on 12/5/03.",
      "product_quantity": "584 Kits",
      "distribution_pattern": "Medical facilities, physicians, diagnostic laboratories, and distributors located nationwide.",
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        "device_name": "C-Reactive Protein, Antigen, Antiserum, And Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5270",
        "device_class": "2",
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