{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Woburn",
      "address_1": "400 Tradecenter",
      "reason_for_recall": "Some strains of Pseudomonas putida cross-react with the P. aeruginosa PNA probe used in E. coli/P. aeruginosa PNA FISH (KT007) due to a sequence similarity resulting in a cross-reaction that may produce a red-positive signal",
      "address_2": "Ste 6990",
      "product_quantity": "33 units",
      "code_info": "Lot Numbers:  01812A-US, 03412A-US and 00512A-EU   Exp Date: 12-2013",
      "center_classification_date": "20121022",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) including: CA, FL, IL, MI, and NJ; and country of: Great Britain.",
      "state": "MA",
      "product_description": "AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit  for Escherichia coli and Pseudomonas aeruginosa   Catalog Number : KT007    Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.",
      "report_date": "20121031",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Advandx Inc",
      "recall_number": "Z-0116-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "63199",
      "termination_date": "20130305",
      "recall_initiation_date": "20120914",
      "postal_code": "01801",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}