{
  "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": "San Diego",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "66294",
      "recalling_firm": "Sekisui Diagnostics LLC",
      "address_1": "6659 Top Gun St",
      "address_2": "",
      "postal_code": "92121-4113",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide Distribution - US  (nationwide) and the countries of UK, Saudi Arabia, Dubai, Kuwait, Poland, Spain, India and Romania",
      "recall_number": "Z-0015-2014",
      "product_description": "Product Name: OSOM C. Difficile Toxin A/B Test  Catalog Numbers: 173 (for United States) and 173 E (for Europe).    The Test is a qualitative assay (in vitro diagnostic) that employs  immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears    The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD.",
      "product_quantity": "391 kits",
      "reason_for_recall": "Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin A/B Test Kit, because it has been determined that there is potential for false negative results.",
      "recall_initiation_date": "20130916",
      "center_classification_date": "20131017",
      "termination_date": "20140505",
      "report_date": "20131023",
      "code_info": "The following are part numbers and lot number combinations.    PN:173E,  LN:121272.  PN:173,  LN:121273.  PN:173,  LN:121273A.  PN:173E,  LN:131155.  PN:173,  LN:131156.",
      "more_code_info": ""
    }
  ]
}