{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Tarrytown",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86504",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "511 Benedict Ave",
      "address_2": "N/A",
      "postal_code": "10591-5005",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "CA, DE, MD, NC, NJ, NY, PA          Foreign:  Argentina¿¿¿¿¿¿  Australia¿¿¿¿¿¿  Brazil¿¿¿¿  Canada¿¿¿¿¿  Czech¿Republic¿  Denmark¿¿¿¿¿¿¿¿  Germany¿¿¿¿¿¿¿¿  Italy¿¿¿¿¿¿¿¿¿¿  Netherlands¿¿¿¿  P.R.¿China¿¿¿¿¿  Paraguay¿¿¿¿¿¿¿  Slovakia¿¿¿¿¿¿¿  Turkey¿¿¿¿¿¿¿¿¿  United¿Kingdom¿  Vietnam¿¿¿¿¿¿¿¿",
      "recall_number": "Z-0101-2021",
      "product_description": "ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems  Siemens Material Number (SMN): 10361941",
      "product_quantity": "US: 23 units; OUS: 204 units",
      "reason_for_recall": "Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.",
      "recall_initiation_date": "20200922",
      "center_classification_date": "20201013",
      "report_date": "20201021",
      "code_info": "All lots  UDI: (01)00630414558073(10)501874(17)20201128 (01)00630414558073(10)514594(17)20210221  (01)00630414558073(10)528971(17)20210630"
    }
  ]
}