{
  "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": "2026-04-15",
    "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": "74654",
      "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": "Letter",
      "distribution_pattern": "Worldwide Distribution - US (Nationwide, Washington DC) Canada; Cuba; Chile; and Dominican Republic.",
      "recall_number": "Z-2770-2016",
      "product_description": "Fluorocell PLT reagent, Catalog #CD994563  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": "3868 units",
      "reason_for_recall": "There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results performed using the recalled lots may exhibit lower than expected PLT-F and IPF values. The issue may be recognized by a large discrepancy between the Impedance platelet (PLT-I) value and a false low PLT-F value. In most cases, the falsely decreased PLT-F results displayed a \"PLT Abn Scattergram\" message with asterisks beside the results indicating the data is unreliable. In rare instances, platelet flags may be absent. The PLT-I counts are unaffected.    The PLT-F is a reflex test used to confirm PLT-I results due to flagging or low values. As such, the likely impact to patient results is low. Affected results display a discrepancy between the PLT-I and PLT-F, with lower than expected PLT-F results that do not match the patient's clinical picture.",
      "recall_initiation_date": "20160701",
      "center_classification_date": "20160909",
      "termination_date": "20170210",
      "report_date": "20160921",
      "code_info": "Lot number A5053, Expiration date 12/21/2016  Lot number A5054, Expiration date 12/21/2016  Lot number A5041, Expiration date 9/2/2016  Lot number A5042, Expiration date 9/2/2016  Lot number A5044, Expiration date 10/2/2016  Lot number A5046, Expiration date 11/9/2016  Lot number A5047, Expiration date 11/17/2016  Lot number A5048, Expiration date 11/17/2016  Lot number A5049, Expiration date 11/26/2016  Lot number A5050, Expiration date 11/26/2016  Lot number A5055, Expiration date 12/24/2016",
      "more_code_info": ""
    }
  ]
}