{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Brea",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63161",
      "recalling_firm": "Beckman Coulter Inc.",
      "address_1": "250 S Kraemer Blvd",
      "address_2": "N/A",
      "postal_code": "92821-6232",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and the following countries:  Albania  Australia  Austria  Bahrain  Bangladesh  Barbados  Belarus  Belgium  Bosnia and Herzegovina  Bulgaria  Burundi  Canada  Chile  China  Colombia  Croatia  Czech Republic  Denmark  Ecuador  El Salvador  Finland  France  French Guiana  French Polynesia  Germany  Greece  Guadeloupe  Hong Kong  India  Indonesia  Iraq  Ireland  Israel  Italy  Japan  Kenya  Korea, Republic of  Kuwait  Libyan Arab Jamahiriya  Lithuania  Macao  Malaysia  Mexico  Monaco  Morocco  Namibia  Netherlands  New Zealand  Nigeria  Norway  Oman  Pakistan  Panama  Poland  Puerto Rico  Qatar  Reunion  Romania  Russian Federation  Saudi Arabia  Singapore  Slovakia  Slovenia  South Africa  Spain  Sudan  Sweden  Switzerland  Taiwan  Turkey  United Arab Emirates  United Kingdom  Uruguay",
      "recall_number": "Z-0035-2013",
      "product_description": "TetraCXP Software System, Part Number A40051.    Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.",
      "product_quantity": "146 units total (37 units in US)",
      "reason_for_recall": "The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5) need to be updated for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping",
      "recall_initiation_date": "20120522",
      "center_classification_date": "20121010",
      "termination_date": "20121010",
      "report_date": "20121017",
      "code_info": "All tetraCHROME lots manufactured"
    }
  ]
}