{
  "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": "2026-04-29",
    "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": "98498",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "511 Benedict Ave",
      "address_2": "",
      "postal_code": "10591-5005",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Domestic: Nationwide Distribution  International: Argentina, Australia, Bangladesh, Brazil, Bulgaria       , Canada, Chile, China, Colombia, Croatia        , Cura¿ao, St Eus, Czech Republic , Denmark        , Ecuador, Egypt          , Estonia        , Finland        , France         , Georgia        , Germany        , Greece         , Hong Kong, India, Iraq           , Italy          , Jordan         , Kuwait         , Latvia         , Lithuania      , Macedonia      , Malaysia, Maldives, Mexico, Netherlands    , New Zealand, Norway         , Oman           , Pakistan       , Paraguay, Qatar          , Romania        , Saudi Arabia   , Serbia         , Singapore, Slovakia       , Slovenia       , South Africa, South Korea, Spain          , Turkey         , Turkmenistan   , U.A.E.         , Uganda         , United Kingdom , Uruguay        , Vatikancity;",
      "recall_number": "Z-1657-2026",
      "product_description": "Atellica CH Enzymatic Hemoglobin A1c (A1c_E);  Siemens Material Number (SMN): 11097536;",
      "product_quantity": "21,291 units (9750 US, 11541 OUS)",
      "reason_for_recall": "A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU).  When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.",
      "recall_initiation_date": "20260223",
      "center_classification_date": "20260327",
      "report_date": "20260408",
      "code_info": "Siemens Material Number (SMN): 11097536; UDI-DI: 00630414220505; Lot numbers: 150131, 150132, 150232, 150260, 150283, 150344, 150361, 150365, 150366, 150445, 150453, 150460, 150498, 150505, 150562, 150600, 150618, 150621;",
      "more_code_info": ""
    }
  ]
}