{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "105402",
      "product_res_number": "Z-0277-2012",
      "event_date_initiated": "2011-05-03",
      "event_date_posted": "2011-11-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-08-07",
      "res_event_number": "60436",
      "product_code": "LNX",
      "product_description": "SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. \n\n\nSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and report laboratory data.",
      "code_info": "SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4.",
      "firm_fei_number": "1000307651",
      "recalling_firm": "SCC Soft Computer",
      "address_1": "5400 Tech Data Drive",
      "city": "Clearwater",
      "state": "FL",
      "postal_code": "33760",
      "additional_info_contact": "Kathryn Branca\n727-789-0100",
      "reason_for_recall": "On 05/03/2011 SCC Soft Computer, Clearwater, FL initiated a correction on the following SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. A client reported the PT and INR results did not get flagged. The PROT should have been flagged as HIGH and the INR should have been flagged as PANIC. Neither test was flagged. All affected clients were notified of the issue on 05/03",
      "root_cause_description": "Software design",
      "action": "SCC Soft Computer initiated a Field correction on May 3, 2011. All customers with affected software have been notified of this issue. Clients were instructed to have a \"valcheck\" utility run to determine if there are any tests in their system affected by the issue. They were supposed to indicate whether they wanted to schedule to receive the patch or hot fix.\n\nIf you have any further questions please call ( 727 ) 789-0100.",
      "product_quantity": "69",
      "distribution_pattern": "Worldwide Distribution-- USA ( nationwide) and Canada.",
      "openfda": {
        "k_number": [
          "K921846"
        ]
      }
    }
  ]
}