{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Grove City",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81172",
      "recalling_firm": "Tosoh Bioscience Inc",
      "address_1": "3600 Gantz Rd",
      "address_2": "N/A",
      "postal_code": "43123-1895",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide distribution. Foreign distribution to Chile, Colombia, Ecuador, Guatemala, Honduras, Panama, Peru, Puerto Rico, Uruguay, and Venezuela.",
      "recall_number": "Z-0602-2019",
      "product_description": "AIA-900 Automated Immunoassay Analyzer performs  three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.",
      "product_quantity": "258",
      "reason_for_recall": "The firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing home detection sensor relay harness on your AIA-900 Analyzer. It is possible that the harnesses could rub against the Plarail chain during operation and result in premature wear. If observed, this issue will cause the following system error to be reported  D.lane Mix home overrun  error [4093] .     If observed, this issue will cause the AIA-900 Analyzer not to function and the  D.lane Mix home overrun  error [4093]  will be reported by the system. Replacement of the motor drive harness and mixing home detection sensor relay harness will mitigate the potential for premature wear and effectively prevent this issue from causing the system error.     If the sensor relay harness fails, the AIA-900 analyzer will cease to function and will be unavailable for use.  If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh is aware of two complaints associated with the unexpected wearing of the harness. There have been no user or patient injuries reported that are related to this device malfunction.",
      "recall_initiation_date": "20170928",
      "center_classification_date": "20181213",
      "termination_date": "20201208",
      "report_date": "20181219",
      "code_info": "All active analyzer serial numbers"
    }
  ]
}