{
  "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": [
    {
      "country": "United States",
      "city": "Grove City",
      "address_1": "3600 Gantz Rd",
      "reason_for_recall": "HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers should exercise caution when reviewing chromatograms and ensure that Flag 43 is enabled on their device to avoid reporting invalid test results in the presence of HbAE.",
      "address_2": "",
      "product_quantity": "665",
      "code_info": "All active analyzers with Version 5.23 Software",
      "center_classification_date": "20180810",
      "distribution_pattern": "Worldwide Distributed - US Nationwide. and the countries of Foreign distribution to Brazil, Caribbean, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Panama, Peru, and Uruguay.",
      "state": "OH",
      "product_description": "G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674    Product Usage:  The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.",
      "report_date": "20180822",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Tosoh Bioscience Inc",
      "recall_number": "Z-2745-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "80257",
      "termination_date": "20210209",
      "more_code_info": "",
      "recall_initiation_date": "20180606",
      "postal_code": "43123-1895",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}