{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
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  "results": [
    {
      "status": "Terminated",
      "city": "Monmouth Junction",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "62537",
      "recalling_firm": "Princeton Biomeditech Corp",
      "address_1": "4242 US Highway 1",
      "address_2": "N/A",
      "postal_code": "08852-1905",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution-including the states of NJ, NY, and PA.",
      "recall_number": "Z-2307-2012",
      "product_description": "Poly stat Flu A &  B Test  Manufactured for   Polymedco  510 Furnace Dock Road  Cortlandt Manor, NY 10567  Tel 800-431-2123         914-739-5400  Fax 914-739-5890.      The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.",
      "product_quantity": "103 kits (22 tests per kit)",
      "reason_for_recall": "There have been reports of dual positive (Flu A + Flu B positive) results being encountered.",
      "recall_initiation_date": "20120309",
      "center_classification_date": "20120831",
      "termination_date": "20141014",
      "report_date": "20120912",
      "code_info": "510 k K083746    Catalog Number FLU22  Lot numbers 441A11, 441C11"
    }
  ]
}