{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "112204",
      "product_res_number": "Z-0039-2013",
      "event_date_initiated": "2012-08-10",
      "event_date_posted": "2012-10-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-12-17",
      "res_event_number": "62968",
      "product_code": "JMM",
      "product_description": "IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles.\n\nThe 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",
      "code_info": "Lot 14541, EXP Nov 2012",
      "firm_fei_number": "3002485711",
      "recalling_firm": "Immunodiagnostics Systems Ltd",
      "address_1": "10 Didcot Way Bolden Business Park",
      "city": "Boldon Tyne & Wear",
      "country": "United Kingdom",
      "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.",
      "root_cause_description": "Labeling False and Misleading",
      "action": "Immunodiagnostics Systems sent Customer notification letters via email and notified customers of the recall. The notification included the reason for recall, product information with codes, lot number, manufacturing/distribution date, and exp date. The notification included instructions to customers: Actions to be taken by the customer:\n\nCustomers should complete the attached Recall and Acknowledgement Form and take the following actions:\n\n1) Check your stock for the products included within the scope of the recall. Cease use and distribution and quarantine all affected product lots immediately.\n\n2) Complete the enclosed Recall & Acknowledgement Form and immediately fax back to Immunodiagnostic Systems. This will allow us to document your receipt of this letter and the amount of product you have on hand for return.\n\n3) Return any affected product freight collect, along with the original completed Recall & Acknowledgement Form to your local IDS office.\nContact information was also provided.\nFor questions regarding this recall call +44 (191) 5195212.",
      "product_quantity": "1",
      "distribution_pattern": "Nationwide Distribution including NY, CA, ME and CT.",
      "openfda": {
        "k_number": [
          "K952320",
          "K952026",
          "K992997",
          "K981364",
          "K945946",
          "K972788",
          "K974260",
          "K983457",
          "K952506",
          "K011052",
          "K963251",
          "K980518",
          "K960171",
          "K961562",
          "K770603",
          "K972580",
          "K990843",
          "K971312",
          "K983674",
          "K980833",
          "K993706"
        ],
        "registration_number": [
          "1528450",
          "9610126",
          "1036362",
          "3007111389",
          "1319681",
          "3007118747",
          "3002806944",
          "3006198300",
          "8021924",
          "2242436"
        ],
        "fei_number": [
          "1036362",
          "3002485711",
          "1000136573",
          "3007111389",
          "3007118747",
          "3002806944",
          "3006198300",
          "1000122536",
          "2242436",
          "3002806559"
        ],
        "device_name": "Column Chromatography & Color Development, Hydroxyproline",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1400",
        "device_class": "1"
      }
    }
  ]
}