{
  "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": "Boldon Tyne & Wear",
      "state": "N/A",
      "country": "United Kingdom",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "62968",
      "recalling_firm": "Immunodiagnostics Systems Ltd",
      "address_1": "10 Didcot Way Bolden Business Park",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide Distribution including NY, CA, ME and CT.",
      "recall_number": "Z-0039-2013",
      "product_description": "IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles.    The Urine BETA CrossLaps¿ ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in human urine. The Urine BETA CrossLaps¿ ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption as an aid in A. Monitoring bone resorption changes of 1) Anti-resorptive therapies in postmenopausal women: a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies B. Predicting skeletal response (Bone Mineral Density) in postmenopausal women undergoing anti-resorptive therapies a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies",
      "product_quantity": "1",
      "reason_for_recall": "It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States.  The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.",
      "recall_initiation_date": "20120810",
      "center_classification_date": "20121010",
      "termination_date": "20121217",
      "report_date": "20121017",
      "code_info": "Lot 14541, EXP Nov 2012"
    }
  ]
}