Events

Recall of Device Recall SoftLab/Mic ASCII Addon

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
    56863
  • Event Risk Class
    Class 2
  • Event Number
    Z-0344-2011
  • Event Initiated Date
    2010-02-16
  • Event Date Posted
    2010-11-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94683
  • 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
    When a test is being verified, the wrong (expired) ranges may be associated to that test result, causing an incorrect flag to be posted for that test result.
  • Action
    Clients were notified via the proprietary communication software on 02/16/2010. The Notification Verbiage identified the affected product and informed clients of the potential hazard, root cause, corrective action, 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

Device Recall SoftLab/Mic ASCII Addon
  • Model / Serial
    Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution - US and Puerto Rico.
  • Product Description
    SoftLab/Mic ASCII Add-on Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || Version 4.0.1.14 Manufactured & Distributed 12/29/2006. || Version 4.0.1.15 Manufactured & Distributed 05/02/2007. || Version 4.0.1.16 Manufactured & Distributed 08/22/2008. || Used in a medical research or clinical laboratory setting by knowledgeable, trained and experienced personnel.
  • 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