{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Tarrytown",
      "address_1": "511 Benedict Ave",
      "reason_for_recall": "The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H)",
      "address_2": "",
      "product_quantity": "Lot 969=33 units (29 units foreign) Lot 970=7 units (42 units foreign)",
      "code_info": "Lots 969 and 970",
      "center_classification_date": "20130107",
      "distribution_pattern": "Worldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico.    Internationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay, Taiwan, and Uraguay,",
      "state": "NY",
      "product_description": "Immunoradiometric assay.    Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.",
      "report_date": "20130116",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics",
      "recall_number": "Z-0646-2013",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "63852",
      "termination_date": "20131028",
      "more_code_info": "",
      "recall_initiation_date": "20121128",
      "postal_code": "10591-5005",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}