Events

Recall of Device Recall SA BASE with SoftLab Version 3.1.4.x.

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
    56865
  • Event Risk Class
    Class 2
  • Event Number
    Z-0364-2011
  • Event Initiated Date
    2010-06-01
  • Event Date Posted
    2010-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94685
  • 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
    Functionality issue: for clients using the instrument to generate results on the interface menu, two different result records could be displayed under the same order and sequence numbers. this could cause incorrect results to be populated to a patient record.
  • Action
    Clients were notified via the proprietary communication software on 06/01/2010. The communication discussed the risk-to-health notification task, 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 SA BASE with SoftLab Version 3.1.4.x.
  • Model / Serial
    Version 3.1.4.x
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including states of CT, FL, IL, KY, GA, LA, IN, MS, NJ, NY, PA, OH, and TN and country of Canada.
  • Product Description
    SA BASE with SoftLab Version 3.1.4.x. || Manufactured 03/2003. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || Intends to provide clients with an interface that links all clinical laboratory departments throughout the enterprise.
  • Manufacturer
    SCC Soft Computer

Manufacturer

SCC Soft Computer