{
  "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": "East Walpole",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90812",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "333 Coney St",
      "address_2": "N/A",
      "postal_code": "02032-1516",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) to states of: FL                   IN                   MA                   MI                   NH                   NJ                   NY                   OH                   TX                   UT                    and OUS (Foreign) countries of: Australia¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Brazil¿¿¿¿¿¿¿¿¿ Czech¿Republic¿ Germany¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ P.R.¿China¿¿¿¿¿ Singapore¿¿¿¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Taiwan¿¿¿¿¿¿¿¿¿ Tunisia¿¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿",
      "recall_number": "Z-1820-2022",
      "product_description": "IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI)  Siemens Material Number (SMN): 10876421 US; 10713448 (OUS)",
      "product_quantity": "100 units US; 328 units OUS",
      "reason_for_recall": "An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results. This may  lead to a delayed follow up of patients with clinical autoimmune thyroid",
      "recall_initiation_date": "20220811",
      "center_classification_date": "20220927",
      "report_date": "20221005",
      "code_info": "UDI-DI:  (01)00630414597188(10)D389S(17)221130  (US);  (01)00630414597171(10)389(17)221130 (OUS) Lot Number: 389 Exp.Date:  2022-11-30"
    }
  ]
}