{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "103941",
      "product_res_number": "Z-0042-2012",
      "event_date_initiated": "2011-06-07",
      "event_date_posted": "2011-10-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-07-06",
      "res_event_number": "59891",
      "product_code": "MSQ",
      "product_description": "IDkit:HP\"  Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience Ltd 4 Ha' maayan St. Modiin, Israel 71700, Distributed by: Exalenz Bioscience Inc., 1313 N. Market St., Sute 5100, Wilmington, DE 19808 USA\n\n\nProduct Usage:  The IDkit:HP Two Test System is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. Urea Breath Tests are well established as reliable, non-invasive methods for detecting H. pylori. They are highly endorsed by various medical societies as the test of choice for initial detection as well as for post-treatment testing.",
      "code_info": "Reorder No. AC00028, Lot numbers: 11-071, 11-0561, 10-00018 and 10-00017.",
      "firm_fei_number": "3005772418",
      "recalling_firm": "Exalenz Bioscience Ltd",
      "address_1": "Hamaayan 4 4 hamaayan",
      "city": "Modiin",
      "country": "Israel",
      "additional_info_contact": "Mark Hood\n704-707-6162",
      "reason_for_recall": "The product is in violation of the FD&C Act in that it was illegally marketed without proper clearance (no 510(k) submitted).",
      "root_cause_description": "No Marketing Application",
      "action": "The firm, Exalenz Bioscience Ltd. notified consignees located in the United States of the recall by telephone, electronic mail, or written correspondence between June 9, 2011 and June 30, 2011.  The letter informed consignees that Exalenz will immediately cease marketing the IDkit:HP TWO test in the United States. Consignees were instructed to return shipment of the IDkit:HP TWO test kits that they have in their possession to the companys US warehouse.  For question call the VP of North American Sales at 704-770-6162 or VP of Marketing at 617-794-6936.",
      "product_quantity": "1240 units",
      "distribution_pattern": "Nationwide Distribution (USA) - including the states of: FL, IL, LA, MA, MS, NY, TN, TX and VA.",
      "openfda": {
        "k_number": [
          "K193610",
          "K000316",
          "K162150",
          "K221896",
          "K130524",
          "K972352",
          "K092817",
          "K173772",
          "K041148",
          "K173777",
          "K093834",
          "K014225",
          "K223185",
          "K990931",
          "K220494",
          "K011668",
          "K973000"
        ],
        "device_name": "Test, Urea (Breath Or Blood)",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3110",
        "device_class": "1",
        "registration_number": [
          "3005772418"
        ],
        "fei_number": [
          "3005772418"
        ]
      }
    }
  ]
}