SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Version 4.1.15.6
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Soft Computer Consultants, Inc.
Reason for Recall:
Software showing wrong results reported, PDF not match HIS.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.

Product Codes/Lot Numbers:

Version 4.1.15.6

Distribution:

Distributed in: US, CA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2093-2021

Related Recalls

SoftCytogenetics

Soft Computer Consultants

Class I - Dangerous

Software is given wrong results going out to HIS on test that had reruns.

Mar 31, 2021 Other Medical Devices Nationwide View Details →

Software error. Potential for incorrect results

Oct 6, 2016 Diagnostic Equipment Nationwide View Details →