{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "41850",
      "product_res_number": "Z-0007-06",
      "event_date_initiated": "2005-08-31",
      "event_date_posted": "2005-10-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-03-16",
      "res_event_number": "33412",
      "product_code": "DHA",
      "k_numbers": [
        "K042676"
      ],
      "product_description": "Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)",
      "code_info": "Lot #62-500262",
      "firm_fei_number": "2050095",
      "recalling_firm": "Nichols Institute Diagnostics",
      "address_1": "1311 Calle Batido",
      "city": "San Clemente",
      "state": "CA",
      "postal_code": "92673-6316",
      "additional_info_contact": "John Chiechi\n949-940-7377",
      "reason_for_recall": "Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months.",
      "root_cause_description": "Other",
      "action": "Withdrawal letter was sent 08/30/2005 which request customers to stop using the product immediately and discard any remaining materials. A response card was included.",
      "product_quantity": "174",
      "distribution_pattern": "Nationwide and China, Germany, & Australia",
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        "medical_specialty_description": "Clinical Chemistry",
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