Events

Recall of Device Recall SoftLab

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
    60455
  • Event Risk Class
    Class 3
  • Event Number
    Z-0444-2012
  • Event Initiated Date
    2011-07-26
  • Event Date Posted
    2012-01-11
  • 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=105440
  • 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
    Scc soft computer, clearwater, fl, initiated a correction for the softlab used with sa inst. a test performed on the roche cobas integra series of instruments when used with the geninst/dispatch listening program could cause incorrect flagging for a test result posted to the lab database.
  • Action
    The firm, SCC Soft Computer, sent a "Correction Communication" letter on July 26, 2011 to customers/consignees. The letter describes the product problem and actions to be taken. The firm will correct the software to recognize and support all known formats of the resulting date and time sent by an instrument. The software is available via a recommended patch or hot fix to the client's current release. The customers were asked to acknowledge receipt of the task and grant permission for SCC to correct the affected configuration files. If you have any questions, call (727) 789-0100.

Device

Device Recall SoftLab
  • Model / Serial
    SoftLab used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9, 4.5.2.0 to 4.5.2.8 and SA INST 3.1.3.0 to 3.1.3.29, 3.1.6.0 to 3.1.6.17, 4.0.0.0, 4.0.1.0 to 4.0.1.32.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (Nationwide) and Country of: Canada.
  • Product Description
    SoftLab used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9, 4.5.2.0 to 4.5.2.8 and SA INST 3.1.3.0 to 3.1.3.29, 3.1.6.0 to 3.1.6.17, 4.0.0.0, 4.0.1.0 to 4.0.1.32. || SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, 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