{
  "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": "184791",
      "product_res_number": "Z-0722-2021",
      "event_date_initiated": "2020-11-23",
      "event_date_created": "2020-12-23",
      "recall_status": "Open, Classified",
      "res_event_number": "86900",
      "product_code": "JQA",
      "product_description": "Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): 11097597",
      "code_info": "All lot codes. UDI: 00630414596440",
      "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": "Gamma-Glutamyl Transferase (GGT) Reagent   Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) listed in the Instructions For Use (IFU) on some analyzers.",
      "root_cause_description": "Device Design",
      "action": "Siemens Healthcare Diagnostics Urgent Field Safety Notice letter beginning November  23, 2020 via Fed Ex and outside the US the distribution is determined at the country level. Letter states reason for recall , health risk and action to take:\nFor the product listed above, please perform the following steps:\n1. Review and apply the preliminary precision performance characteristics of d8% CV at a GGT concentration of approximately 27 U/L  42 U/L provided.\n2. Please review this letter with your Medical Director.\n3. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days.\n4. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative.\nPlease retain this letter with your laboratory records and forward this letter to those who may have received this product.\nContact your Siemens Customer Care Center or your local Siemens technical support representative.\n\nThe precision section of the IFUs will be updated when the investigation is\ncomplete. The updated IFUs will be uploaded into Document Library where all registered users who opt in to receive alerts will be notified of the updated IFU.",
      "product_quantity": "731 units US; 16824 units OUS",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Australia, Austria, Bahamas, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, India, Iran, Ireland, Israel, Italy, Japan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Philippines, Poland, Portugal, Qatar, Republic Korea, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, Uruguay, Vatican City, Vietnam.\n¿¿¿¿\n¿¿¿¿¿",
      "openfda": {
        "device_name": "Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1360",
        "device_class": "1",
        "registration_number": [
          "2432235",
          "3004493545"
        ],
        "fei_number": [
          "2432235",
          "3004493545"
        ]
      }
    }
  ]
}