{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "121955",
      "product_res_number": "Z-0015-2014",
      "event_date_initiated": "2013-09-16",
      "event_date_posted": "2013-10-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-05-05",
      "res_event_number": "66294",
      "product_code": "LLH",
      "k_numbers": [
        "K102242"
      ],
      "product_description": "Product Name: OSOM C. Difficile Toxin A/B Test\nCatalog Numbers: 173 (for United States) and 173 E (for Europe).\n\nThe Test is a qualitative assay (in vitro diagnostic) that employs\nimmunochromatographic, 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\n\nThe 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.",
      "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.",
      "firm_fei_number": "1000520007",
      "recalling_firm": "Sekisui Diagnostics LLC",
      "address_1": "6659 Top Gun St",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-4113",
      "additional_info_contact": "858-777-2600",
      "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.",
      "root_cause_description": "Other",
      "action": "Sekisui Diagnostic sent an Customer Recall Notification letter dated  September 16, 2013, via email and/or FedEx. The letter identified the product the problem and the action needed to be taken by the customer. \n\nThe customer notification letter informs the customers that Sekisui Diagnostics has issued a Product Correction for certain lots of the OSOM C. difficile Toxin A/B Test Kit (P/N 173). The customer notification lists the reason for recall, instructions to the customer, product description, required actions, and contact information. Customer Notification Letter lists the specific lot numbers being recalled for that catalog number. For each of these two catalog numbers, there is one letter directed to a distributor and one letter directed to an end user. Customer letters will be sent by email and/or FedEx. The letters have REQUIRED ACTIONS outlined in a box. If no response is received within 30 days, there will be directed follow-up communication. \n\nFor further questions please call ( 858) 777-2600.",
      "product_quantity": "391 kits",
      "distribution_pattern": "Worldwide Distribution - US  (nationwide) and the countries of UK, Saudi Arabia, Dubai, Kuwait, Poland, Spain, India and Romania",
      "openfda": {
        "k_number": [
          "K913229",
          "K091109",
          "K102242",
          "K964887",
          "K030404",
          "K041003",
          "K870864",
          "K924136",
          "K050891",
          "K991829",
          "K935296",
          "K032897",
          "K993914",
          "K852044",
          "K990664",
          "K914902",
          "K923463",
          "K883560",
          "K905211",
          "K030992",
          "K003306",
          "K964864",
          "K971182",
          "K080931",
          "K090239",
          "K030991",
          "K980185",
          "K033479",
          "K924979",
          "K934493",
          "K081920",
          "K193490",
          "K041951",
          "K082499",
          "K863485",
          "K931129",
          "K926442",
          "K911958",
          "K072138",
          "K955859",
          "K903456",
          "K925329"
        ],
        "device_name": "Reagents, Clostridium Difficile Toxin",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2660",
        "device_class": "1",
        "registration_number": [
          "3026664926",
          "3024463179",
          "8020790",
          "3016733849",
          "8010096",
          "1924669",
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          "3014684020",
          "3004530258",
          "3016838963",
          "3009171251",
          "3002792284",
          "3009935129"
        ],
        "fei_number": [
          "3026664926",
          "3004185580",
          "3024463179",
          "3005670738",
          "3016733849",
          "1924669",
          "3006440892",
          "3003750284",
          "2024674",
          "3033751096",
          "3033507883",
          "3006759904",
          "1000186023",
          "1000123404",
          "2013736",
          "1524213",
          "3021090658",
          "3014684020",
          "3004530258",
          "3006224287",
          "3016838963",
          "3002792284",
          "1000611339",
          "3009935129"
        ]
      }
    }
  ]
}