{
  "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": "Terminated",
      "city": "East Walpole",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80954",
      "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": "US Nationwide Distribution",
      "recall_number": "Z-0116-2019",
      "product_description": "Atellica IM CKMB Calibrator, Cat No. 10995532    Product Usage:    For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.",
      "product_quantity": "97 kits",
      "reason_for_recall": "A potential bias was identified with certain kits compared to the internal standards.",
      "recall_initiation_date": "20180724",
      "center_classification_date": "20181015",
      "termination_date": "20200526",
      "report_date": "20181024",
      "code_info": "SMN 10995532    Lot # Expiry UDI #  57837A66 2018-12-11 (01)00630414598598(10)57837A66(17)20181211  67443A66 2018-12-11 (01)00630414598598(10)67443A66(17)20181211"
    }
  ]
}