Recall of Soft Lab

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by SCC Soft Computer.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Calculator/data processing module, for clinical use - Product Code JQP
  • Reason
    On 10/17/2011 scc soft computer, clearwater, fl initiated a correction on softlab with sa inst versions:,,, and a client reported an issue which caused two different sets of results from the sysmex series of hematology instruments to display under the same order on the instrument menu.
  • Action
    SCC Soft Computer's proprietary Task Management System sent a correction communication letter to all consignees with affected software. The letter identified the affected product, problem and corrective actions to be taken. The letter also recommended alternative working solution if the corrective actions cannot be used. Consignees with affected software are scheduling receipt of the software correction. For questions call 727-789-0100.


  • Model / Serial
    SA INST versions:,,, and
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    US Nationwide Distribution
  • Product Description
    SoftLab with SA INST versions:,,, and || Product UsageSoftLab 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 reporting laboratory data.
  • Manufacturer


  • Manufacturer Address
    SCC Soft Computer, 5400 Tech Data Drive, Clearwater FL 33760
  • Manufacturer Parent Company (2017)
  • Source