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 Soft Computer Consultants, Inc..

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
    77669
  • Event Risk Class
    Class 2
  • Event Number
    Z-2865-2017
  • Event Initiated Date
    2017-05-31
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157452
  • 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
    Software, transmission and storage, patient data - Product Code NSX
  • Reason
    Display of lab results based on incorrect loinc code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the emr.
  • Action
    The firm, SCC Soft Computer, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 05/31/2017to its consignees. The letter described the product, problem and actions to be taken. The consignees were informed that the issue will be corrected with a mandatory hotfix. The Consignees were instructed to acknowledge receipt of the recall notice by signing the recall notice and calling Technical Support at 800-763-8522 to grant permission to load the hotfix. For questions or concerns, please call 800-763-8522 Technical Support, available 24/7, and for any adverse reactions/quality problems experienced with the use of this product are to be reported to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax.

Device

Device Recall SoftLab
  • Model / Serial
    Versions 4.5.4.3, 4.5.4.5, 4.5.4.6, 4.5.4.8, 4.5.4.9, 4.5.4.20, 4.5.4.30, 4.5.4.40, 4.5.5.0, 4.5.5.10, and 4.5.5.20
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.
  • Product Description
    SoftLab Software || Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
  • Manufacturer
    Soft Computer Consultants, Inc.

Manufacturer

Soft Computer Consultants, Inc.
  • Manufacturer Address
    Soft Computer Consultants, Inc., 5400 Tech Data Dr, Clearwater FL 33760-3116
  • Manufacturer Parent Company (2017)
    Soft Computer Consultants Inc.
  • Source
    USFDA