{
  "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": 4
    }
  },
  "results": [
    {
      "cfres_id": "214304",
      "product_res_number": "Z-2086-2025",
      "event_date_initiated": "2025-06-04",
      "event_date_posted": "2025-07-03",
      "recall_status": "Open, Classified",
      "res_event_number": "97037",
      "product_code": "KRZ",
      "k_numbers": [
        "K840261"
      ],
      "product_description": "ADVIA 120/2120/2120i SETpoint Calibrator",
      "code_info": "Siemens Material Number 10312285; UDI: 00630414224343, 00630414224343; Lot No. SP251033, SP251043.",
      "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\n1-800-888-7436",
      "reason_for_recall": "Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.",
      "root_cause_description": "Under Investigation by firm",
      "action": "An Urgent Medical Device Correction notification dated 6/4/25 was mailed to consignees. This notification provides consignees with calibration instructions given the issue found in affected lots. Additionally, instructions are given on how to proceed with product depending on performance. Consignees are to discontinue use of and discard of the calibrator SETPOINT lots impacted by this recall. Consignee locations are to review the provided notification with their Medical Directors to determine the appropriate course of action. A copy of the recall notification should be retained in laboratory records and shared with users. Consignees are to complete and return the provided Effectiveness Check Form within 30 days of receipt of the recall notification. Consignees with any questions can contact their Siemens Customer Care Center or local Siemens Healthineers technical support representative.",
      "product_quantity": "2,020 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of AR, AU, BR, CA, CL, CN, CO, CR, HK, ID, IN, JP, KR, MX, MY, PE, PY, SA, SG, TH, TW, UY, VN, & ZA.",
      "openfda": {
        "k_number": [
          "K962864",
          "K822046",
          "K883851",
          "K873832",
          "K843695",
          "K893984",
          "K882600",
          "K951071",
          "K902892",
          "K854166",
          "K840261",
          "K831872",
          "K896921",
          "K822327",
          "K883703",
          "K800852",
          "K052101",
          "K871283",
          "K842668",
          "K831306",
          "K792358",
          "K883850",
          "K831814",
          "K840010",
          "K041130"
        ],
        "registration_number": [
          "1950302",
          "2050012",
          "3014150341",
          "3005333358",
          "1064608",
          "3007603826",
          "1219029",
          "2915274",
          "2432235",
          "2182501",
          "3023162659",
          "9610126",
          "3000148879",
          "3016438761",
          "3003741796",
          "3005146313",
          "1064130",
          "2050010",
          "2221819"
        ],
        "fei_number": [
          "1950302",
          "3003071743",
          "2050012",
          "3014150341",
          "3005333358",
          "3007603826",
          "1219029",
          "3002684533",
          "2915274",
          "2432235",
          "2182501",
          "3023162659",
          "3000148879",
          "3016438761",
          "3003741796",
          "3002806559",
          "3005146313",
          "2050010",
          "2221819"
        ],
        "device_name": "Calibrator For Hemoglobin And Hematocrit Measurement",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.8165",
        "device_class": "2"
      }
    }
  ]
}