{
  "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": "2026-09-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "221448",
      "product_res_number": "Z-2881-2026",
      "event_date_initiated": "2026-06-26",
      "event_date_posted": "2026-08-04",
      "recall_status": "Open, Classified",
      "res_event_number": "99381",
      "product_code": "LFG",
      "k_numbers": [
        "K821743"
      ],
      "product_description": "Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls\nSMN 10445390\nCatalog No. 7C219UL",
      "code_info": "UDI-DI 00842768014321\nLot U2",
      "firm_fei_number": "1219913",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "333 Coney St",
      "city": "East Walpole",
      "state": "MA",
      "postal_code": "02032-1516",
      "additional_info_contact": "Louise Mclaughlin\n508-668-5000",
      "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.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On June 26, 2026, the firm began notifying customers via Urgent Medical Device Correction letters. Customers were informed of the issue and provided with revised Safety Data Sheets (SDS) specific to the impacted lots for handling and disposal information.",
      "product_quantity": "494 US; 114 OUS",
      "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.",
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        ],
        "device_name": "Radioimmunoassay, Tricyclic Antidepressant Drugs",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3910",
        "device_class": "2"
      }
    }
  ]
}