Events

Recall of Device Recall SoftMic GUI versions: 4.0.3.04.0.3.15, 4.0.4.14.0.4.7.

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
    Recall
  • Event ID
    60459
  • Event Risk Class
    Class 2
  • Event Number
    Z-0466-2012
  • Event Initiated Date
    2011-08-25
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105453
  • 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 08/25/2011, scc soft computer initiated a correction on the following softmic gui versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7. for clients using softmic result entry, when a certain series of keystrokes on the test grid are performed while entering results and statusing a test, the test status may not be maintained upon saving. the status may be removed or copied from another test on the order.
  • Action
    SCC Soft Computer initiated a Field Correction dated August 25, 2011. to all affected customers. Customers with the affected software have been notified and are scheduling receipt of the hot fix.. Further questions call (727) 789-0100.

Device

Device Recall SoftMic GUI versions: 4.0.3.04.0.3.15, 4.0.4.14.0.4.7.
  • Model / Serial
    SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and Canada.
  • Product Description
    SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7. || SoftMic is a laboratory information system to be used in medical research, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data.
  • Manufacturer
    SCC Soft Computer

Manufacturer

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