Reported Jul 28, 2021 · Terminated

SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a…

Soft Computer Consultants, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Soft Computer Consultants, Inc. · 5400 Tech Data Dr · Clearwater, FL · 33760-3116

Is this the product you have?

  • 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.
Lot codes and dates
  • Version 4.1.15.6
Amount recalled
1

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Software showing wrong results reported, PDF not match HIS.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 15, 2022 · Data as of Sep 19, 6:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.