{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "199537",
      "product_res_number": "Z-1504-2023",
      "event_date_initiated": "2023-03-16",
      "event_date_posted": "2023-05-03",
      "recall_status": "Open, Classified",
      "res_event_number": "92059",
      "product_code": "JFT",
      "k_numbers": [
        "K142723"
      ],
      "product_description": "Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.",
      "code_info": "Atellica IM Cortisol (50T) UDI-DI: 00630414598659;\nKit Lot Numbers: 50732343\n50733343\n88975345\n29106347\n29107347 and higher;\n\nAtellica IM Cortisol 250T UDI-DI: 00630414598642;\nKit Lot Numbers: 50734343\n88974345\n29105347 and higher;\n\nAtellica IM Cortisol (REF) 250T UDI-DI: 00630414293608;\nKit Lot Numbers: 53842343\n58039343\n94430345 and higher",
      "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": "Customer Care Center\n312-275-7795",
      "reason_for_recall": "There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.",
      "root_cause_description": "Under Investigation by firm",
      "action": "An Urgent Medical Device Correction notification letter dated 3/17/23 was sent to customers.\n\nActions to be Taken by the Customer\nDiscontinue use of urine patient samples with the Atellica IM Cortisol and ADVIA Centaur Cortisol assays until further notice.\nCustomers may continue to use serum and plasma sample types with the Atellica IM Cortisol and ADVIA Centaur Cortisol assays.\nPlease review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.\nComplete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days.\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.\n\nPlease retain this letter with your laboratory records and forward this letter to those who may have received this product.\n\nWe apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.\n\nAn additional Resolution Customer Notification letter dated 2/29/24 was sent to customers explaining an improvement to raw material specification that restores assay performance with urine samples. Customers are asked to follow the instructions for urine patient samples and urine cortisol QC as stated in the notification and if using products listed in the original field action notice continue following the guidance as stated in the Field Action Letter. Customers with any questions are to contact the Customer Care Center or local Siemens Healthineers technical support representative.",
      "product_quantity": "34,746 kits",
      "distribution_pattern": "Worldwide distribution - US Nationwide.",
      "openfda": {
        "k_number": [
          "K863422",
          "K962559",
          "K934317",
          "K893954",
          "K926322",
          "K900010",
          "K833932",
          "K931031",
          "K895421",
          "K152227",
          "K142723",
          "K852927",
          "K192788",
          "K954591",
          "K930732",
          "K021218",
          "K854419",
          "K062204",
          "K242505",
          "K033731"
        ],
        "registration_number": [
          "3008344661",
          "3002809144",
          "1219913",
          "8020790",
          "3005529799",
          "8020888",
          "1181121",
          "8031673",
          "9610126",
          "3002637618",
          "3005333358",
          "9612316",
          "2432235"
        ],
        "fei_number": [
          "3008344661",
          "3002806559",
          "3007019572",
          "3002809144",
          "1219913",
          "1000611339",
          "3005529799",
          "3002637618",
          "3002808328",
          "1181121",
          "2432235",
          "2967",
          "3005333358"
        ],
        "device_name": "Fluorometric, Cortisol",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1205",
        "device_class": "2"
      }
    }
  ]
}