{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "197426",
      "product_res_number": "Z-0949-2023",
      "event_date_initiated": "2022-12-07",
      "event_date_posted": "2023-01-11",
      "recall_status": "Open, Classified",
      "res_event_number": "91310",
      "product_code": "MSW",
      "k_numbers": [
        "K982468"
      ],
      "product_description": "IMMULITE 2000 Thyroglobulin  (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi)  for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy.\nCatalog # L2KTY2(D)\nSiemens Material Number (SMN): 10381647",
      "code_info": "UDI: 00630414972084\nKit Lots:  D431, D433, D434, D435, and D436",
      "firm_fei_number": "2432235",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "511 Benedict Ave",
      "city": "Tarrytown",
      "state": "NY",
      "postal_code": "10591-5005",
      "additional_info_contact": "SAME\n914-631-8000",
      "reason_for_recall": "Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots;\ncontrol level one may result outside of published ranges;\nwhen control results are in range, users may observe increased imprecision with low level patient samples",
      "root_cause_description": "Under Investigation by firm",
      "action": "Siemens Healthcare issued An Urgent Medical Device Correction (UMDC) to US affected customers by FedEx beginning 12/08/2022.  An Urgent Field Safety Notice (UFSN) was issued to OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities beginning on 12/07/2022. \nLetter states reason for recall, health risk and action to take:\nDiscontinue use and discard Thyroglobulin kit lots listed in Table 1.\nPlease review this letter with your Medical Director, including consideration for review of previously generated results as outlined above in Risk to Health.\nComplete and return Field Correction Effectiveness Check Form attached to this letter within 30 days.\nReview your inventory of these products determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities.\nIf you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.\nPlease retain this letter with your laboratory records and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.",
      "product_quantity": "717 kits",
      "distribution_pattern": "Nationwide\nForeign:\nArgentina¿¿¿¿¿¿\nAustralia¿¿¿¿¿¿\nAustria¿¿¿¿¿¿¿¿\nBahrain¿¿¿¿¿¿¿¿\nBangladesh¿¿¿¿¿\nBelgium¿¿¿¿¿¿¿¿\nBolivia¿¿¿¿¿¿¿¿\nBosnia¿Herzeg.¿\nBrazil¿¿¿¿¿¿¿¿¿\nBulgaria¿¿¿¿¿¿¿\nCanada¿¿¿¿¿¿¿¿¿\nChile¿¿¿¿¿¿¿¿¿¿\nColombia¿¿¿¿¿¿¿\nCosta¿Rica¿¿¿¿¿\nCroatia¿¿¿¿¿¿¿¿\nCyprus¿¿¿¿¿¿¿¿¿\nCzech¿Republic¿\nDominican¿Rep.¿\nEcuador¿¿¿¿¿¿¿¿\nEgypt¿¿¿¿¿¿¿¿¿¿\nEstonia¿¿¿¿¿¿¿¿\nFinland¿¿¿¿¿¿¿¿\nFrance¿¿¿¿¿¿¿¿¿\nGeorgia¿¿¿¿¿¿¿¿\nGermany¿¿¿¿¿¿¿¿\nGreece¿¿¿¿¿¿¿¿¿\nHonduras¿¿¿¿¿¿¿\nHong¿Kong¿¿¿¿¿¿\nHungary¿¿¿¿¿¿¿¿\nIndia¿¿¿¿¿¿¿¿¿¿\nIndonesia¿¿¿¿¿¿\nIran¿¿¿¿¿¿¿¿¿¿¿\nIraq¿¿¿¿¿¿¿¿¿¿¿\nIreland¿¿¿¿¿¿¿¿\nIsrael¿¿¿¿¿¿¿¿¿\nItaly¿¿¿¿¿¿¿¿¿¿\nJordan¿¿¿¿¿¿¿¿¿\nKA\nKazakhstan¿¿¿¿¿\nKosovo¿¿¿¿¿¿¿¿¿\nKyrgyzstan¿¿¿¿¿\nLatvia¿¿¿¿¿¿¿¿¿\nLithuania¿¿¿¿¿¿\nMacedonia¿¿¿¿¿¿\nMalaysia¿¿¿¿¿¿¿\nMexico¿¿¿¿¿¿¿¿¿\nMorocco¿¿¿¿¿¿¿¿\nNepal¿¿¿¿¿¿¿¿¿¿\nNetherlands¿¿¿¿\nP.R.¿China¿¿¿¿¿\nPakistan¿¿¿¿¿¿¿\nPanama¿¿¿¿¿¿¿¿¿\nParaguay¿¿¿¿¿¿¿\nPeru¿¿¿¿¿¿¿¿¿¿¿\nPhilippines¿¿¿¿\nPoland¿¿¿¿¿¿¿¿¿\nPortugal¿¿¿¿¿¿¿\nRepublic¿Korea¿\nRomania¿¿¿¿¿¿¿¿\nRussian¿Fed.¿¿¿\nSaudi¿Arabia¿¿¿\nSerbia¿¿¿¿¿¿¿¿¿\nSingapore¿¿¿¿¿¿\nSlovakia¿¿¿¿¿¿¿\nSlovenia¿¿¿¿¿¿¿\nSouth¿Africa¿¿¿\nSpain¿¿¿¿¿¿¿¿¿¿\nSweden¿¿¿¿¿¿¿¿¿\nSwitzerland¿¿¿¿\nTaiwan¿¿¿¿¿¿¿¿¿\nTrinidad,Tobago\nTunisia¿¿¿¿¿¿¿¿\nTurkey¿¿¿¿¿¿¿¿¿\nTurkmenistan¿¿¿\nU.A.E.¿¿¿¿¿¿¿¿¿\nUkraine¿¿¿¿¿¿¿¿\nUnited¿Kingdom¿\nUruguay¿¿¿¿¿¿¿¿\nUzbekistan¿¿¿¿¿\nVietnam¿¿¿¿¿¿¿¿",
      "openfda": {
        "k_number": [
          "K031269",
          "K002905",
          "K982468",
          "K994140",
          "K021057",
          "K982466",
          "K221890",
          "K002888",
          "K241423",
          "K991720",
          "K240927",
          "K220972",
          "K242981"
        ],
        "registration_number": [
          "2020726",
          "8031673",
          "3006198300",
          "9612316",
          "1219913",
          "2521625",
          "3015529350",
          "9610126",
          "2122870",
          "2025560",
          "2432235",
          "1036362",
          "3002806944"
        ],
        "fei_number": [
          "2020726",
          "3002806944",
          "3006198300",
          "2967",
          "3002808328",
          "1219913",
          "2521625",
          "3015529350",
          "2122870",
          "2025560",
          "2432235",
          "1036362",
          "3002806559"
        ],
        "device_name": "System, Test, Thyroglobulin",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.6010",
        "device_class": "2"
      }
    }
  ]
}