CLASS II Device recall · Reported 21 May 2014 · FDA Enforcement Report

SCC SA HIS recalled by SCC Soft Computer

SCC Soft Computer is recalling SCC SA HIS, distributed in Illinois. The recall was initiated on 29 Jan 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSA HIS version 4.0.7.0

Quantity recalled1

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1573-2014
FDA event ID: 67970
Recalling firm: SCC Soft Computer, Clearwater, FL
Classification: Class II
Status: Terminated
Recall initiated: 29 Jan 2014
FDA classified: 9 May 2014
Reported: 21 May 2014
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Other Reasons
Device type: Medical Software

Timeline

29 Jan 2014	Recall initiated by company
9 May 2014	Classified by FDA	+100 days
21 May 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

When an isolate is resulted without a SNOMED code, isolate information in the downstream system may be incomplete or missing. As a result, there is the potential for the delay or omission of patient treatment updates.

Product as listed by the FDA

SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data.

Where it was distributed

Distributed in IL.

Illinois

Questions about this recall

Is SCC SA HIS recalled?

Yes. SCC Soft Computer recalled SCC SA HIS on 29 Jan 2014. The recall is Class II and its status is Terminated. Recall number Z-1573-2014.

Why was it recalled?

Which lots are affected?

SA HIS version 4.0.7.0

Where was it sold?

Distributed in IL.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from SCC Soft Computer

All 4

Reported	Class	Recall	Company	Reason	Where
18 Feb 2015Device	CLASS II	SoftPath Laboratory Information System recalled by SCC Soft Computer	SCC Soft Computer	Other	Nationwide
11 Feb 2015Device	CLASS II	SoftLab with SA HIS versions 0.7.0-4.0.7.1 SoftLab is recalled	SCC Soft Computer	Other	Nationwide
15 Aug 2012Device	CLASS II	SoftLab with SA INST versions recalled by SCC Soft Computer	SCC Soft Computer	Other	Nationwide

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