{
  "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,
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  "results": [
    {
      "cfres_id": "160060",
      "product_res_number": "Z-0515-2018",
      "event_date_initiated": "2017-06-07",
      "event_date_created": "2018-02-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-05-08",
      "res_event_number": "78645",
      "product_code": "CHP",
      "k_numbers": [
        "K100293"
      ],
      "product_description": "ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack.\nSiemens Material Number (SMN): 10379810, 10379811, 10697756.",
      "code_info": "Lot Numbers: 00387A21, 16673A21, 36243A21;  00388A21, 15448A21, 51211A21;  20640A21; 51024A21.  Expiration Date: 2018-03-08",
      "firm_fei_number": "1219913",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc",
      "address_1": "333 Coney St",
      "city": "East Walpole",
      "state": "MA",
      "postal_code": "02032-1516",
      "additional_info_contact": "508-668-5000",
      "reason_for_recall": "Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when calibrating with Calibrator 30 kit lots ending in 21 (C3021) as compared to Calibrator 30 kit lots ending in 20 (C3020).",
      "root_cause_description": "Under Investigation by firm",
      "action": "An Urgent Medical Device Recall letter dated June 7, 2017 was distributed to all customers in the United States and an\nUrgent Field Safety Notice was distributed to all customers outside the United States who have\nreceived ADVIA Centaur Systems Calibrator 30 kit lot ending in 21(C3021). These letters instruct\ncustomers who operate the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT\nsystems to discontinue use of C3021 . The letters inform customers that Calibrator 30 kit lots\nending in 20 (C3020) and 23 (C3023) are not impacted and can be used. The letters inform\ncustomers who operate ADVIA Centaur CP systems to continue using their inventory of C3021,\nas they are not impacted by this issue.\n\nAll affected domestic customers were sent a hard copy of the Urgent Medical Device Recall via\nFederal Express. Fax-back forms will be used to confirm that the customers received the Urgent\nMedical Device Recall letter.",
      "product_quantity": "5992 units (US and OUS)",
      "distribution_pattern": "US and OUS.",
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        "device_name": "Radioimmunoassay, Estradiol",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1260",
        "device_class": "1"
      }
    }
  ]
}