{
  "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": "2026-08-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "East Walpole",
      "state": "MA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99381",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "333 Coney St",
      "address_2": "",
      "postal_code": "02032-1516",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states CA, ID, IL, IN, MA, MS, NC, NM, NY, OH, OK, OR, PA, WA, and Northern Mariana Islands part of USA and the countries of Canada, South Africa, Brazil, Chile, Colombia.",
      "recall_number": "Z-2881-2026",
      "product_description": "Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls  SMN 10445390  Catalog No. 7C219UL",
      "product_quantity": "494 US; 114 OUS",
      "reason_for_recall": "out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.",
      "recall_initiation_date": "20260626",
      "center_classification_date": "20260804",
      "report_date": "20260812",
      "code_info": "UDI-DI 00842768014321 Lot U2",
      "more_code_info": ""
    }
  ]
}