{
  "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": [
    {
      "status": "Terminated",
      "city": "Sparks",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "62505",
      "recalling_firm": "Becton Dickinson & Co.",
      "address_1": "BD Diagnostic Systems",
      "address_2": "7 Loveton Circle",
      "postal_code": "21152-0999",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution including CA, DE, FL, GA, IL, IN, KS, KY, ME, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TX, VA, WA, WI, and WV.",
      "recall_number": "Z-2319-2012",
      "product_description": "BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests   2-3 labeled  in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***    BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.",
      "product_quantity": "32 kits",
      "reason_for_recall": "Leakage in Cepheid SmartCycler reaction tubes.",
      "recall_initiation_date": "20120522",
      "center_classification_date": "20120906",
      "termination_date": "20121102",
      "report_date": "20120912",
      "code_info": "Lot/ Exp. 08T11250 2012-07-06"
    }
  ]
}