{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "cfres_id": "192329",
      "product_res_number": "Z-0928-2022",
      "event_date_initiated": "2022-02-09",
      "event_date_created": "2022-04-14",
      "recall_status": "Open, Classified",
      "res_event_number": "89740",
      "product_code": "CJY",
      "k_numbers": [
        "K083386"
      ],
      "product_description": "Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644",
      "code_info": "UDI: 00630414220697;\nLot Numbers: 211392\n211438\n211484\n211522\n211526",
      "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": "914-631-8000",
      "reason_for_recall": "Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.",
      "root_cause_description": "Device Design",
      "action": "Urgent Medical Device Correction notification letters dated 2/9/22 were sent to customers.\n\nActions to be Taken by the Customer\nPlease review this letter with your Medical Director.\nPerform the instructions provided in the  Additional Information  section below.\nComplete and return the Field Correction Effectiveness Check Form attached to this letter\nwithin 30 days.\nIf you have received any complaints of illness or adverse events associated with the\nproducts listed in Table 1, immediately contact your local Siemens Healthineers Customer\nCare 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 these products.\n\nAdditional Information\nIf your laboratory has multiple Atellica CH 930 Analyzers, separate the assays as follows:\n-LITH_2 from CA_2 and TBil_2\n-A1c_E/A1c_H from CA_2\n- CA_2 from UN_c (urine only); UN_c serum and plasma are not impacted and can be run on the same analyzer as CA_2\n-Fruc from AAT, IgA_2, IgM_2 and Theo\n\nIf you choose not to separate the assays as indicated above, batch testing of A1c_E, Fruc, LITH_2, and UN_c (urine only) may be considered.\nNote: An RPC2 wash mitigation must be initiated after completion of A1c_E, Fruc, LITH_2, and\nprior to UN_c (urine only). Any of the following will initiate the RPC2 wash:\n-After the Atellica CH 930 Analyzer has been in standby for 12 minutes.\n- After completion of any Open Channel assay.\n- Restarting the Atellica CH 930 Analyzer. Refer to the Atellica Solution Online Help for\ninstructions on system restart.\n\nIf you have any questions, contact your local Siemens Healthineers technical support representative.",
      "product_quantity": "2,395",
      "distribution_pattern": "Global Distribution.  US Nationwide.",
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        ],
        "device_name": "Azo Dye, Calcium",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1145",
        "device_class": "2",
        "registration_number": [
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