{
  "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": "Lincolnshire",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80716",
      "recalling_firm": "Sysmex America, Inc.",
      "address_1": "577 Aptakisic Rd",
      "address_2": "N/A",
      "postal_code": "60069-4325",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide Distribution: US (Nationwide) including Puerto Rico; and countries of: Argentina, Brazil, Canada, Chile, Costa Rica, Ecuador, Honduras,  and Nicaragua.",
      "recall_number": "Z-2953-2018",
      "product_description": "Sysmex XN-Series Fluorocell PLT, Catalog #CD994563.   Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL.     Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers.",
      "product_quantity": "5,168 units",
      "reason_for_recall": "The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT.",
      "recall_initiation_date": "20180727",
      "center_classification_date": "20180830",
      "termination_date": "20190708",
      "report_date": "20180905",
      "code_info": "Reagent lot numbers: A7125, exp. date 01/9/2019; A7126, exp. date 01/11/2019; A7127, exp. date 01/09/2019, A7128, exp. 01/15/2019; A7129, exp. 01/15/2019; A7130, exp. 01/17/2019; A7131, exp. 01/17/2019, A8003, exp. 01/31/2019; A8004, exp. 01/31/2019; A8005, exp. 02/04/2019; and A8006, exp. 02/04/2019."
    }
  ]
}