{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "130224",
      "product_res_number": "Z-0122-2015",
      "event_date_initiated": "2014-09-19",
      "event_date_posted": "2014-10-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-11-18",
      "res_event_number": "69321",
      "product_code": "CGR",
      "k_numbers": [
        "K931409"
      ],
      "product_description": "IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD.\n\nFor in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.",
      "code_info": "Lots: 381 (exp. 10/31/2014), 382 (exp. 10/31/2014) and 383 (exp. 11/30/2014)",
      "firm_fei_number": "2432235",
      "recalling_firm": "Siemens Healthcare Diagnostics",
      "address_1": "511 Benedict Ave",
      "city": "Tarrytown",
      "state": "NY",
      "postal_code": "10591-5005",
      "reason_for_recall": "Customer complaints were received for positive bias reported on the controls used on the IMMULITE /IMMULITE 1000 on the Cortisol Assay reagent lots IMMULITE /IMMULITE 1000 (LKCO1) Lots 381,382 and 383 .  Subsequently, the firm confirmed a positive bias on the IMMULITE/IMMULITE 1000 (LKCO1) Lots 381, 382 and 383.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "US Customers were sent an Urgent Medical Device Recall Letter (UMDR2014-09-19, dated 9/19/14) via FedEx on 9/19/14.  Outside US Customers were sent an Urgent Field Safety Notice Letter.   The letters inform the consignees of the recall of the IMMULITE/IMMULITE 1000 Cortisol (LKCO1) assay, kit lots 381, 382 and 383.  Customers were asked to take the following actions: - Please review this letter with your Medical Director.  - Discontinue use of and discard the IMMULITE/IMMULITE 1000 Cortisol kit lots listed in the letter. -  Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. --- Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Field Safety Notice letter within thirty (30) days.",
      "product_quantity": "US: 772 units, Canada: 43 units",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and internationally to Canada.",
      "openfda": {
        "k_number": [
          "K810891",
          "K800045",
          "K822892",
          "K791700",
          "K800538",
          "K862871",
          "K901296",
          "K800245",
          "K821068",
          "K050202",
          "K202826",
          "K841641",
          "K203270",
          "K821931",
          "K840466",
          "K060480",
          "K802036",
          "K954733",
          "K820074",
          "K820341",
          "K782110",
          "K832638",
          "K914886",
          "K852939",
          "K062626",
          "K872177",
          "K931409",
          "K780725",
          "K202136",
          "K771117",
          "K802380",
          "K903975",
          "K884689",
          "K761346",
          "K781903",
          "K984520",
          "K760939",
          "K223038",
          "K792243",
          "K042689",
          "K831141",
          "K895407",
          "K943427",
          "K905473",
          "K800594",
          "K931177",
          "K843384",
          "K945367",
          "K870969",
          "K834219",
          "K842455",
          "K900485",
          "K810192",
          "K850141",
          "K791835",
          "K822845",
          "K792036",
          "K842365",
          "K792439",
          "K850008",
          "K830148",
          "K760256",
          "K895006",
          "K052359",
          "K790268",
          "K922676",
          "K983990",
          "K843183",
          "K242190",
          "K802969",
          "K862336",
          "K801203",
          "K790906",
          "K842554",
          "K810033",
          "K800700",
          "K880687",
          "K896451",
          "K781730",
          "K010790",
          "K962208",
          "K830563",
          "K842957",
          "K940221"
        ],
        "device_name": "Radioimmunoassay, Cortisol",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1205",
        "device_class": "2",
        "registration_number": [
          "9612296",
          "3000308930",
          "1319681",
          "2245285",
          "3011989923",
          "3022178699",
          "2250051",
          "1036362",
          "3012963943",
          "3002800697",
          "2020726",
          "3007118747",
          "2122870",
          "8021924",
          "3002642396",
          "3006198300",
          "3007111389",
          "3002806944"
        ],
        "fei_number": [
          "3000308930",
          "2245285",
          "3011989923",
          "3022178699",
          "1000136573",
          "1036362",
          "3012963943",
          "2250051",
          "3002800697",
          "2020726",
          "3007118747",
          "3002485711",
          "3002807663",
          "2122870",
          "3002642396",
          "3006198300",
          "3007111389",
          "3002806944"
        ]
      }
    }
  ]
}