Events

Recall of Device Recall SoftPath GUI

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
    60458
  • Event Risk Class
    Class 2
  • Event Number
    Z-0363-2012
  • Event Initiated Date
    2011-07-20
  • Event Date Posted
    2011-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105445
  • 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 07/20/2011 scc soft computer, clearwater, fl, initiated a correction on the following softpath gui versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12. a client reported that the hpv results on a patient report were incorrect. the hpv results were from the previous order on the patient and not the current order. all affected clients were notified about the issue on 07/20/2011.
  • Action
    SCC Soft Computer sent a "CORRECTION COMMUNICATION" dated July 20, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. SCC personnel will review the customized Lab Results AP macro and/or the Micro Results AP macro on customer systems and will either discuss with them the irregularities requiring change or reconfigure macros as necessary.

Device

Device Recall SoftPath GUI
  • Model / Serial
    SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the country of Canada.
  • Product Description
    SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12. || SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material.
  • 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