{
  "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": 2
    }
  },
  "results": [
    {
      "cfres_id": "221572",
      "product_res_number": "Z-2975-2026",
      "event_date_initiated": "2026-07-13",
      "event_date_posted": "2026-08-17",
      "recall_status": "Open, Classified",
      "res_event_number": "99446",
      "product_code": "LBZ",
      "k_numbers": [
        "K922913"
      ],
      "product_description": "Syva EMIT 2000 Quinidine Assay\nREF: 4Q019UL\nContents: 1x28 mL, 1x14mL",
      "code_info": "Lot U1/UDI: 00842768001048",
      "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": "Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "On July 14, 2026, Simens Healthineers issued a Urgent Medical Device Correction notification via FedEx. Simens asked consignees to take the following actions:\n\n1. Review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.\n\n2. Discontinue use of and discard the kit lots listed in the Products Section.\n\n3. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days.\n\n4. Retain this letter with your laboratory records and forward this letter to those who may have received this product.",
      "product_quantity": "20 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the state of CA and the country of Italy.",
      "openfda": {
        "k_number": [
          "K832493",
          "K842713",
          "K032332",
          "K900705",
          "K011605",
          "K850808",
          "K822653",
          "K052826",
          "K840596",
          "K872175",
          "K941440",
          "K955568",
          "K964116",
          "K811460",
          "K822588",
          "K904990",
          "K830963",
          "K862214",
          "K922913",
          "K892208",
          "K964212",
          "K843237",
          "K831355",
          "K864607",
          "K812753",
          "K860049",
          "K832096"
        ],
        "registration_number": [
          "3010939897",
          "2517506",
          "3003795116",
          "3005333358",
          "9610126",
          "9610529",
          "3006198300"
        ],
        "fei_number": [
          "3010939897",
          "2517506",
          "3003795116",
          "3002806559",
          "3005333358",
          "3002806560",
          "3006198300"
        ],
        "device_name": "Enzyme Immunoassay, Quinidine",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3320",
        "device_class": "2"
      }
    }
  ]
}