Events

Recall of SoftLab GUI Version 4.0.1.0 4.0.1.16, 4.0.2.0 4.0.2.10, 4.0.3.0 4.0.3.13, and 4.0.4.0 4.0.4.

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
    56867
  • Event Risk Class
    Class 2
  • Event Number
    Z-0365-2011
  • Event Initiated Date
    2009-04-01
  • Event Date Posted
    2010-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94701
  • 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
    Clients using patient maintenance to perform moves of stays may send the wrong billing number during an adt update to softweb, softpath or softmedia. the wrong billing number can come from a different patient in order entry. only moves of stays are affected.
  • Action
    Clients were notified via the proprietary communication software on 06/01/2009. This is a MANDATORY CORRECTION. The Risk-To-Health Notification Task gives the background on the issue, the potential hazard, root cause, corrective action, alternative working solution, and requested action. Clients were instructed to acknowledge receipt of the notification. If the client wishes to receive the correction, they should document a request to load the software.

Device

SoftLab GUI Version 4.0.1.0 4.0.1.16, 4.0.2.0 4.0.2.10, 4.0.3.0 4.0.3.13, and 4.0.4.0 4.0.4.
  • Model / Serial
    Versions: 4.0.1.0 - 4.0.1.16; 4.0.2.0 - 4.0.2.10; 4.0.3.0 - 4.0.3.13; and 4.0.4.0 - 4.0.4.5.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    SoftLab GUI Version 4.0.1.0 - 4.0.1.16, 4.0.2.0 - 4.0.2.10, 4.0.3.0 - 4.0.3.13, and 4.0.4.0 - 4.0.4.5. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || Manufacture/Distribution Dates: || 4.0.1.0 - 08/06/04, || 4.0.1.4 - 10/18/04, || 4.0.1.5 - 01/18/04, || 4.0.1.6 - 12/15/04, || 4.0.1.7 - 01/10/05, || 4.0.1.8 - 03/29/05, || 4.0.1.9 - 05/06/05, || 4.0.1.13 - 01/25/06, || 4.0.1.14 - 03/26/07 || 4.0.1.15 - 05/02/07, || 4.0.1.16 - 08/22/08, || 4.0.2.0 - 04/08/05, || 4.0.2.1 - 08/13/08, || 4.0.2.2 - 06/06/05, || 4.0.2.3 - 09/19/05, || 4.0.2.4 - 09/19/05, || 4.0.2.5 - 09/19/05, || 4.0.2.7 - 02/13/06, || 4.0.2.8 - 12/12/06, || 4.0.2.9 - 02/20/08, || 04.2.10 - 08/13/08, || 4.0.3.2 - 05/17/06, || 4.0.3.3 - 09/18/06, || 4.0.3.4 - 09/27/06, || 4.0.3.5 - 11/29/06, || 4.0.3.6 - 06/22/07, || 4.0.3.7 - 03/28/07, || 4.0.3.8 - 06/22/07, || 4.0.3.9 - 08/03/07, || 4.0.3.10 - 08/24/07, || 4.0.3.11 - 09/24/07, || 4.0.3.12 - 03/07/08, || 4.0.3.13 - 06/13/08, || 4.0.4.2 - 02/22/08, || 4.0.4.3 - 05/22/08, || 4.0.4.4 - 07/28/08, || 4.0.4.5 - 05/04/09. || Intends to provide clients with an interface that links all clinical laboratory departments throughout the enterprise.
  • 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