{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "219899",
      "product_res_number": "Z-2362-2026",
      "event_date_initiated": "2026-04-16",
      "event_date_posted": "2026-06-09",
      "recall_status": "Open, Classified",
      "res_event_number": "98830",
      "product_code": "OTA",
      "k_numbers": [
        "K250159"
      ],
      "product_description": "Brand Name: EXENT Analyser\nProduct Name: EXENT Analyser\nModel/Catalog Number: IE800.A\nSoftware Version: 1.0.20\nProduct Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays.",
      "code_info": "Lot Code: Model No; IE800A; EXENT Analyser; UDI; 05051700020886, Serial Number; 101150, Software version; v1.0.20.",
      "firm_fei_number": "3002808340",
      "recalling_firm": "The Binding Site Group, Ltd.",
      "address_1": "8 Calthorpe Road",
      "city": "Birmingham",
      "country": "United Kingdom",
      "additional_info_contact": "44 121 456 9500",
      "reason_for_recall": "It was reported that plates 2 and 3 were marked as  passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Firm notified customers via \"Urgent Medical Device Correction\" letter dated April 14, 2026.\n\nCustomers were advised to confirm QC results are present in the QC results screen for the corresponding plate barcode after the completion of each plate measurement. If no QC result is displayed, do not release results from that plate and repeat the run ensuring QC material is properly loaded. The customer should also contact US Technical Support. \n\nWhen performing multi-plate runs while loading a previously used QC vials, ensure newly opened QCs are loaded onto Reagent Runner 2 as well, or discard and load newly opened QC vials into Reagent Runner 1.\n\nRetrospective review of previously released results is not considered necessary by the recalling firm.\n\nPlease maintain awareness of the issue until Thermo Fisher Scientific identifies and implements a software enhancement that addresses the issue.",
      "product_quantity": "1",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "registration_number": [
          "9614373",
          "3012471076"
        ],
        "fei_number": [
          "3002808340",
          "3012471076"
        ],
        "device_name": "Mass Spectrometer For Clinical Multiplex Test Systems",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2570",
        "device_class": "2"
      }
    }
  ]
}