Reported Feb 18, 2015 · Terminated

SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15,…

SCC Soft Computer

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: SCC Soft Computer · 5400 Tech Data Drive · Clearwater, FL · 33760

Is this the product you have?

  • SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0
Lot codes and dates

8 of 8 products

Products covered by this recall
#Product as published
107/31/2009 - Present
2Version 4.3.0.9 Release date: 11/23/2009 - Present
3Version 4.3.0.10 Release date: 09/20/2010- Present
4Version 4.3.0.11 Release date: 11/11/2010- Present
5Version 4.3.0.12 Release date: 02/07/2011- Present
6Version 4.3.0.14 Release date: 11/14/2012- Present
7Version 4.3.0.15 Release date: 09/17/2013- Present
8Version 4.4.0.1 Release date: 12/13/2013 - Present
Amount recalled
108 units

Where it was sold

  • Nationwide

Why it was recalled

Modifications to diagnostic text may be: 1) Saved to the database but not appear on the report sent to the physician; or 2) Documented on the report, but not saved to the database.

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 May 16, 2016 · Data as of Sep 19, 6:03 PM UTC

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