Reported Aug 9, 2017 · Terminated

SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by…

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?

  • SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
Lot codes and dates
    • 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
Amount recalled
18 units

Where it was sold

Why it was recalled

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.

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 Aug 4, 2020 · Data as of Sep 19, 5:21 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.