{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Newark",
      "state": "DE",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92461",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 Gbc Dr",
      "address_2": "N/A",
      "postal_code": "19702-2466",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of CA, CO, FL, IL, KY, LA, MA, MD, MI, MS, MT, NC, NH, NY, OH, PA, SC, TN, TX, VA, WA, & WV. The countries of Australia, Brazil, Canada, China, France, Germany, Greece, Italy, Portugal, Saudi Arabia, Spain, Sweden, & United Kingdom.",
      "recall_number": "Z-2091-2023",
      "product_description": "Aptio Automation Storage and Retrieval Module (SRM)",
      "product_quantity": "83 units",
      "reason_for_recall": "A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result.     The mis-association of test results, or a delay in testing, may occur when all the conditions listed below occur within a few milliseconds\u0019 timeframe of each other:      - The SRM module is releasing a sample tube (Tube A) just placed into the carrier      - Another sample tube (Tube B) is erroneously not diverted into the SRM module buffer     - There is divert gate malfunction and a narrow timing window    Only in this specific scenario, Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without a unique error message being generated.   The Automation System loses the traceability of Tube A. It manages both Tube A (incorrectly identified as Tube B) and the real Tube B according to the pending test orders (not yet performed) on Tube B.",
      "recall_initiation_date": "20230516",
      "center_classification_date": "20230705",
      "report_date": "20230712",
      "code_info": "Model No. 10713762 and 10715227; UDI-DI: 00630414596754; All units with software versions prior to 38."
    }
  ]
}