{
  "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": "221446",
      "product_res_number": "Z-2880-2026",
      "event_date_initiated": "2026-06-26",
      "event_date_posted": "2026-08-04",
      "recall_status": "Open, Classified",
      "res_event_number": "99379",
      "product_code": "KLR",
      "k_numbers": [
        "K801204"
      ],
      "product_description": "Syva Emit Disopyramide Assay\nEnzyme Immunoassay, Lidocaine\nSMN 10445370\nCatalog No 6N319UL",
      "code_info": "UDI-DI 00842768001406\nLot U1",
      "firm_fei_number": "2517506",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 Gbc Dr",
      "city": "Newark",
      "state": "DE",
      "postal_code": "19702-2466",
      "additional_info_contact": "Louise Mclaughlin\n800-441-9250",
      "reason_for_recall": "Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. 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 6/26/2026, Siemens issued Urgent Medical Device Correction letters to all affected customers informing them of the issue and providing instructions. \n\nCustomers are instructed to refer to the SDS which were created and provided with the\nUrgent Medical Device Corrections and the Urgent Field Safety Notices specifically for\nSyva Emit Disopyramide Assay Lot U1 for information regarding handling and disposal.",
      "product_quantity": "8 US; 44 OUS",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.",
      "openfda": {
        "k_number": [
          "K881116",
          "K033809",
          "K823866",
          "K831354",
          "K833379",
          "K833623",
          "K090282",
          "K801204",
          "K853010",
          "K802131",
          "K833381",
          "K822347",
          "K823887",
          "K832799",
          "K032334",
          "K973102",
          "K843184"
        ],
        "registration_number": [
          "2432235",
          "3010825766",
          "3010939897",
          "2517506",
          "9610126"
        ],
        "fei_number": [
          "2432235",
          "3010825766",
          "3010939897",
          "2517506",
          "3002806559"
        ],
        "device_name": "Enzyme Immunoassay, Lidocaine",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3555",
        "device_class": "2"
      }
    }
  ]
}