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SCC SOFT COMPUTER

US

Last updated September 17, 2026

Information

Country
US
Address
5400 TECH DATA DR., CLEARWATER, FL, 33760
Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
1000307651
DUNS Number
131311409

Catalogue (718)

Page 15 of 15
DeviceModel / ReferenceRegistriesClassStatus
SoftCytogenetics 4.1.17.23
FDA UDI
Class IActive
SoftPathDx 4.1.17.12
FDA UDI
Class IActive
SoftPathDx 3.5.59.0
FDA UDI
Class IActive
SoftMolecular 4.1.11.22
FDA UDI
Class IActive
SoftGenePortal 4.1.17.20
FDA UDI
Class IActive
SoftGenePortal 4.1.17.249
FDA UDI
Class IActive
SoftBank 25.5.6.0
FDA UDI
Class IIActive
SoftFlowCytometry 4.1.11.21
FDA UDI
Class IActive
SoftCytogenetics 4.1.17.10
FDA UDI
Class IActive
SoftMolecular 4.1.17.5
FDA UDI
Class IActive
SoftROE 4.0.9.0
FDA UDI
Class IActive
SoftBiobank 1.0.1.7
FDA UDI
Class IActive
SoftFlowCytometry 4.1.17.249
FDA UDI
Class IActive
SoftMic 4.1.17.14
FDA UDI
Class IActive
SoftFlowCytometry 4.2.0.15
FDA UDI
Class IActive
SoftIWS 4.1.11.20
FDA UDI
Class IActive
SoftCytogenetics 4.1.17.233
FDA UDI
Class IActive
SoftBank 25.6.1.2
FDA UDI
Class IIActive

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FDA Recalls (33)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Nov 26, 2014Z-1065-2015—terminated

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.

May 20, 2014Z-1038-2015—terminated

The interface fails to send abnormal flags for Reference Lab test results.

Jan 29, 2014Z-1573-2014—terminated

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.

Oct 25, 2011Z-0362-2012—terminated

On 10/25/2011 SCC Soft Computer, Clearwater, FL initiated a correction on the SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. When SoftReports Designer opened a layout, the system did not load the layout with the previously saved value in the NewPage property. This caused multiple patient records to be printed on the same page. All affected clients were notified on the issue on

Oct 17, 2011Z-2143-2012—terminated

On 10/17/2011 SCC Soft Computer, Clearwater, FL initiated a correction on SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. A client reported an issue which caused two different sets of results from the Sysmex series of Hematology instruments to display under the same order on the instrument menu.

Aug 25, 2011Z-0466-2012—terminated

On 08/25/2011, SCC Soft Computer initiated a correction on the following SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7. For clients using SoftMic Result Entry, when a certain series of keystrokes on the test grid are performed while entering results and statusing a test, the test status may not be maintained upon saving. The status may be removed or copied from another test on the order

Aug 8, 2011Z-0261-2012—terminated

On 08/08/2011 SCC Soft Computer, Clearwater, FL initiated a correction on following SoftLab used with: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x. A client reported a flagging error where the result was flagged as critical in the Instrument Menu but the printed report did not show the corresponding flag. All affected clients were notified of the issue on 0

Jul 26, 2011Z-0444-2012—terminated

SCC Soft Computer, Clearwater, FL, initiated a correction for the SoftLab used with SA INST. A test performed on the Roche Cobas Integra series of instruments when used with the GenInst/Dispatch listening program could cause incorrect flagging for a test result posted to the lab database.

Jul 20, 2011Z-0363-2012—terminated

On 07/20/2011 SCC Soft Computer, Clearwater, FL, initiated a correction on the following SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12. A client reported that the HPV results on a patient report were incorrect. The HPV results were from the previous order on the patient and not the current order. All affected clients were notified about the issue on 07/20/2011.

Jul 13, 2011Z-0209-2012—terminated

Soft Computer, Clearwater, FL, initiated a correction on the following SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. SoftPath architecture does not correctly handle AP macros and data fields inside report sections that are stored in the database. Improper information can be displayed in all places where the diagnosis from the database is read and displayed.

Jun 13, 2011Z-0355-2012—terminated

On 06/13/2011, SCC Soft Computer initiated a correction on the following SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. A client reported when they verified the contents of the fax reports, they found one of the specimen diagnoses to be missing. Parts A through D were present as well as Part F, however, Part E diagnosis was missing for one of the patient reports. All affected clients wer

May 3, 2011Z-0488-2012—terminated

On 05/03/2011, SCC Soft Computer, Clearwater, FL, initiated a correction on the following SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16; 4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8. A client reported that results were not flagged correctly. This can occur when a test is ordered in Order Entry, then collected

May 3, 2011Z-0277-2012—terminated

On 05/03/2011 SCC Soft Computer, Clearwater, FL initiated a correction on the following SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. A client reported the PT and INR results did not get flagged. The PROT should have been flagged as HIGH and the INR should have been flagged as PANIC. Neither test was flagged. All affected clients were notified of the issue on 05/03

Mar 22, 2011Z-0278-2012—terminated

Potential for patient data to be sent to the wrong patient record. A software change affected how the Softlab handles recovery from certain types of table access conflicts. When such conflicts occur, this function has the potential to cause faulty writing to the database.

Jul 19, 2010Z-0088-2011—terminated

Softmic system may delay or omit reporting of clinically significant results including organisms and drug sensitivities. Incomplete culture results may appear complete. SCC Soft Computer is issuing a Correction for SoftMic Versions 4.0.4.7-4.5.1.3 software due to this potential hazard.

Jun 23, 2010Z-2714-2011—terminated

SCC Soft Computer is issuing a correction for SoftReports Versions 1.1.6.x released 02/2008 and 1.1.7.x released 06/2008. Potential hazard - when using SoftReports Layout Designer, results displayed in the report may not match the patient information in the report header.

Jun 22, 2010Z-0362-2011—terminated

SCC Soft Computer is issuing a Correction for SoftBank II Versions: 23.1.2.x, 23.2.0.x, and 25.0.0.x software applications. Functionality issue - For clients generating patient history reports using Patient>Reports>Batch Reports>History Report option in SoftBank with SoftReports activated for patient reports, when the report is generated for more than one patient ALL of the results for the qualif

Jun 1, 2010Z-0364-2011—terminated

Functionality issue: For clients using the instrument to generate results on the interface menu, two different result records could be displayed under the same order and sequence numbers. This could cause incorrect results to be populated to a patient record.

Feb 16, 2010Z-0344-2011—terminated

When a test is being verified, the wrong (expired) ranges may be associated to that test result, causing an incorrect flag to be posted for that test result.

Aug 28, 2009Z-0360-2011—terminated

SCC Soft Computer issued a Correction for SoftID.NET versions 2.0.0.6 - 2.0.0.19. When using the Cancel functionality, if the collection list refreshes during the transaction and changes the position of the patient on the list, the wrong patient order can be cancelled. All affected clients have been notified.

Apr 1, 2009Z-0365-2011—terminated

Clients using Patient Maintenance to perform Moves of Stays may send the wrong billing number during an ADT update to SoftWeb, SoftPath or SoftMedia. The wrong billing number can come from a different patient in Order Entry. Only Moves of Stays are affected.

Jan 26, 2009Z-0102-2011—terminated

For SoftPath GUI versions 4.2.3.4, 4.2.4.1, 403.0.3, and 4.3.0.4., the Previous Patient History and some QA Management reports may have missing or incorrect diagnosis text. However, the patient final report, HIS resulting and Query display are all correct. All affected clients have been provided corrected software..

Oct 5, 2007Z-0069-2011—terminated

SCC Soft Computer, Clearwater, FL issued a Correction for Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.0.2.40.1, and 4.0.2.41.1 on 10/05/2007. A software anomaly in the result reporting interface caused result comments entered after an empty line not to be sent to the HIS system. This included interpretative comments, results, and normal range c

Mar 28, 2007Z-0067-2011—terminated

SCC Soft Computer, Clearwater, FL issued a Correction for SoftPath GUI Releases 3.17 and 4.1 in March 2007 for clients with high volume output of final reports who use the Batch Print for Final Reports in the Scheduler, there is a potential for some reports not printing. This issue was corrected for the one affected user in October 2003.

Aug 4, 2006Z-0100-2011—terminated

For SoftLab version 4.01 ASCII, the qualifying test result does not reach the Call List because the order is locked by either another application, or two Hosparams (HISRR_RBS_sync and Auto_sync_RBS). This creates a lock on the RBS server. The problem was identified in the RBS "C" rule which sends qualifying results to the Call List for SoftLab. All affected clients received the upgrade for Soft

Jun 8, 2006Z-0099-2011—terminated

If a case number is re-used in SoftWeb with SoftPath, the SoftPath case is linked to the original MRN in SoftWeb. This causes SoftPath cases being linked to the wrong patient in SoftWeb. Incorrect results on the patient with original MRN and no results on the patient with the second MRN (and the reused case number) are displayed in SoftWeb Results Query. SCC Soft Computer issued a Correction for

Feb 23, 2006Z-2329-2008—terminated

Loss of text misrepresented individual tissue diagnosis on the final diagnosis print out from the HIS system software. The specimen heading "J" was removed and the diagnosis appeared under the specimen heading "I" as a result the specimen with the heading "I" had two diagnosis.

Feb 23, 2006Z-2463-2008—terminated

In the creation of revised report and supplemental reports diagnosis, text was inserted from another case.

Nov 30, 2004Z-0074-2011—terminated

Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1 HIS may display incorrect collection data for a procedure or test result. Clients using HBO Star RR interface to query for results on a canceled test may see the previous occurrence of the test with the current date and time displayed as the collection date and time instead of the correct collection date and time sent by the SCC interf

Oct 27, 2004Z-1243-06—terminated

Text from one case is overwriting another. This could cause an incorrect diagnostic report to be sent to a clinician/surgeon.

Mar 11, 2004Z-0090-2011—terminated

For clients using the SoftPath GUI version 3.17.6.3.1 Results Reporting interface with parsed text and having the auto correct and auto formatting functions active in MS Word, there is a possibility for some ANSI characters/symbols to be translated incorrectly to ASCII. SCC Soft Computer initiated a Correction in March 2004 for all affected clients.

Dec 30, 2003Z-0089-2011—terminated

SoftPath Cases with Word Perfect documents that were not signed out in ASCII are printing in GUI as a converted document from Word Perfect to PDF document instead of the current MS Word Document. This affects clients upgrading from ASCII to SoftPath GUI 3.17.7.6 Version. All affected clients have been notified and corrections have been made.

Jan 9, 2001Z-1252-06—terminated

The client had made a decision to use the SoftPath Module in a nonstandard manner. Under specific circumstances, incorrect text may appear on a patient report.