{
  "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": "Completed",
      "city": "Lincolnshire",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78134",
      "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 including Puerto Rico) Internationally to New Zealand, Brazil, India, Philippines, Nicaragua, Argentina, Australia, Chile, Viet Nam, Colombia, Pakistan, Malaysia, Dubai, Germany, Hong Kong, Bangladesh, Uruguay Thailand, China, Saudi Arabia, Taiwan, Honduras, Ecuador, Kuwait, South Korea, and Costa Rica",
      "recall_number": "Z-0045-2018",
      "product_description": "Sysmex Fluorocell(R) PLT   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": "23,239 units (9353 US)",
      "reason_for_recall": "There is potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) results  obtained using the lots listed above may exhibit lower than actual PLT-F and IPF values. The issue may be recognized by a large discrepancy between the impedance platelet (PLT-I) result and the PLT-F result. In most cases, the falsely decreased PLT-F results display a \u001cPLT Abn Scattergram\u001d message with an asterisk beside the result or an Action Message:  \u001cDifference between PLT and PLT- F. Check the results.\u001d These are indicators of unreliable data. In rare instances, platelet flags may be absent. The PLT-I results are unaffected.",
      "recall_initiation_date": "20170908",
      "center_classification_date": "20171024",
      "report_date": "20171101",
      "code_info": "Lot Numbers:  A6051  A6052  A6053  A6054  A6055  A6056  A6057  A6058  A6059  A6060  A6061  A6062  A6063  A6064  A6065  A6066  A6067  A6068  A6069  A6070  A6071  A6072  A6073  A6074  A6075  A6076  A6077  A6078  A6079  A6080  A6081  A6082  A6083  A6084  A6085  A6086  A6087  A6088  A6089  A6090"
    }
  ]
}