Events

Recall of Device Recall SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0.

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
    67970
  • Event Risk Class
    Class 2
  • Event Number
    Z-1573-2014
  • Event Initiated Date
    2014-01-29
  • Event Date Posted
    2014-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126682
  • 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 an isolate is resulted without a snomed code, isolate information in the downstream system may be incomplete or missing. as a result, there is the potential for the delay or omission of patient treatment updates.
  • Action
    On 2/10/2014 SCC Soft Computer used a proprietary task management system to send a Correction Communication to the consignee with the affected software. The letter identifies the product, problem and corrective actions.

Device

Device Recall SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0.
  • Model / Serial
    SA HIS version 4.0.7.0
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in IL.
  • Product Description
    SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. || SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, 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