{
  "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": "190786",
      "product_res_number": "Z-0440-2022",
      "event_date_initiated": "2021-12-01",
      "event_date_created": "2021-12-29",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-07-07",
      "res_event_number": "89211",
      "product_code": "JZG",
      "product_description": "Atellica CH 2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of 2-microglobulin in human serum and plasma\nSiemens Material Number (SMN): 11097635",
      "code_info": "Lot Number: 211446\nUDI: 00630414595566",
      "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": "SAME\n914-631-8000",
      "reason_for_recall": "2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on patient samples of up to -10.5% at a B2M concentration of approximately 15 mg/L",
      "root_cause_description": "Under Investigation by firm",
      "action": "Siemens issued An Urgent Medical Device Correction (UMDC) letter to US customers by FedEx beginning on 2021-12-01.  An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities beginning on 2021-12-01.\nLetter states reason for recall, health risk and action to take:\nDiscontinue use of and discard the kit lot listed in Table 1.\nReview your inventory of this product to determine your laboratory s replacement needs and\nto provide information to Siemens Healthineers for reporting to the authorities.\nPlease review this letter with your Medical Director.\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\nproduct 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 this product.\n\nIf you have any questions, contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.",
      "product_quantity": "US: 46 units   OUS: 794 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of CA, CO,  MA, MD, MS, NC, NE, NH, OH, VA, WI and the countries of Argentina, Australia, Austria, Belgium,\nBrazil, Bulgaria, Czech Republic, Denmark, Ecuador, France, Germany, Greece, India, Iran, Israel, Italy, Japan, Mexico, Morocco, Oman, P.R. China, Pakistan, Philippines, Portugal, Slovakia, South Africa, Spain, Switzerland, Turkey, United Kingdom, Uruguay.",
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          "K110874",
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          "K880719",
          "K161297",
          "K895496",
          "K072078",
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        ],
        "registration_number": [
          "2432235",
          "9612316",
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        ],
        "fei_number": [
          "3002808328",
          "2432235",
          "2245285",
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          "3004493545",
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          "3003795116"
        ],
        "device_name": "System, Test, Beta-2-Microglobulin Immunological",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5630",
        "device_class": "2"
      }
    }
  ]
}