Skip to content

Scc Soft Computer

United Statesfrom the FDA registration address FDA FEI 1000307651

Scc Soft Computer is a medical device manufacturer, with 859 devices listed in FDA GUDID (FDA Class I and II) and 38 FDA recalls as of 13 Nov 2026.

Devices
859
Registrations
FDA
FDA recalls
38

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 859
Device classes
  • FDA Class I 819
  • FDA Class II 40
FDA recalls
Identifiers
  • FDA FEI 1000307651
  • DUNS 131311409

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

What Scc Soft Computer makes

SCC Soft Computer makes clinical laboratory information system application software, blood bank information system application software, and bedside information system application software. Their products include SoftPathDx, SoftLab, SoftBiochemistry, SoftMic, SoftHLA, SoftGenomics, SoftTrack, SoftMolecular, and related variants.

These devices are classified as Class I and Class II medical devices and are listed in the FDA UDI registry.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue859

Newest first, rows 1-50 of 859

Search and filter all 859 devices
Skip device list

Rows 1-50 of 859

Showing 1-50 of 859

Company details

FDA FEI number
1000307651
DUNS number
131311409
Address
5400 TECH DATA DR., CLEARWATER, FL, 33760

FDA recalls38

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 33 recalls initiated by SCC SOFT COMPUTER, the earliest on 2001-01-09 and the most recent on 2014-11-26. By recorded status: 33 terminated. The reasons filed fall into these groups: software or firmware, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 1
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 2
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

35 initiated before 2017

Showing the 10 most recent of 38 recalls.

  • 2021

    • 31 Mar 2021 Z-2093-2021 Class II Terminated Software showing wrong results reported, PDF not match HIS. Distribution: US Distribution to: CA only
    • 31 Mar 2021 Z-2098-2021 Class II Terminated Software is given wrong results going out to HIS on test that had reruns. Distribution: US Nationwide Distribution in the states of CA, FL, MN and NJ.

  • 2017

    • 31 May 2017 Z-2865-2017 Class II Terminated 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. Distribution: US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.

  • 2016

    • 6 Oct 2016 Z-1097-2017 Class II Terminated Software error. Potential for incorrect results Distribution: Worldwide Distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY,…
      Full distribution text Worldwide Distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, WI, WV, and the countries of Hawaii and Puerto Rico Canada & Jamaica
    • 6 Oct 2016 Z-1098-2017 Class II Terminated Software error. Potential for incorrect results Distribution: Worldwide Distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY,…
      Full distribution text Worldwide Distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, WI, WV, and the countries of Hawaii and Puerto Rico Canada & Jamaica

  • 2014

    • 26 Nov 2014 Z-1065-2015 Class II 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. Distribution: Distribution US Nationwide and CANADA.
    • 20 May 2014 Z-1038-2015 Class II Terminated The interface fails to send abnormal flags for Reference Lab test results. Distribution: Distributed US (nationwide) in the states of OH, GA, NJ, WI, FL, NH, IL, NY, IN, CA, AL, VA, MO, MI, KY, MA, PA, CO, ME,…
      Full distribution text Distributed US (nationwide) in the states of OH, GA, NJ, WI, FL, NH, IL, NY, IN, CA, AL, VA, MO, MI, KY, MA, PA, CO, ME, TN, WA, MN, SD, LA, NC, and NV and the country of Canada.
    • 29 Jan 2014 Z-1573-2014 Class II 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. Distribution: Distributed in IL.

  • 2011

    • 25 Oct 2011 Z-0362-2012 Unclassified (pre-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 Distribution: Nationwide Distribution.
    • 17 Oct 2011 Z-2143-2012 Class II 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. Distribution: US Nationwide Distribution
Show the 25 most recent of 38 recalls

  • 2011

    • 25 Aug 2011 Z-0466-2012 Unclassified (pre-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 Distribution: Worldwide Distribution -- USA (nationwide) and Canada.
    • 8 Aug 2011 Z-0261-2012 Unclassified (pre-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 Distribution: Worldwide Distribution - USA ( nationwide) and Canada.
    • 26 Jul 2011 Z-0444-2012 Unclassified (pre-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. Distribution: Worldwide Distribution - USA (Nationwide) and Country of: Canada.
    • 20 Jul 2011 Z-0363-2012 Unclassified (pre-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. Distribution: Worldwide Distribution-USA (nationwide) and the country of Canada.
    • 13 Jul 2011 Z-0209-2012 Unclassified (pre-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. Distribution: Worldwide distribution: USA (nationwide) including states of: AR, AL, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD,…
      Full distribution text Worldwide distribution: USA (nationwide) including states of: AR, AL, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NH, NJ, NY, OH, OK, PA, SD, TX, VA, WA, WI, WV including Puerto Rico; country of Canada.
    • 13 Jun 2011 Z-0355-2012 Unclassified (pre-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 Distribution: Class II Recall - Worldwide Distribution -- USA (nationwide) and the country of Canada.
    • 3 May 2011 Z-0277-2012 Unclassified (pre-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 Distribution: Worldwide Distribution-- USA ( nationwide) and Canada.
    • 3 May 2011 Z-0488-2012 Unclassified (pre-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 Distribution: Worldwide Distribution - USA (nationwide) and the country of: Canada.
    • 22 Mar 2011 Z-0278-2012 Unclassified (pre-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. Distribution: Sold throughout US and Canada.

  • 2010

    • 19 Jul 2010 Z-0088-2011 Unclassified (pre-2012) 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. Distribution: Worldwide Distribution: USA, including the states of CA, CT, DE, FL, IA, KY, MA, MA, MI, MN, NJ, NY, OH, PA, TX, VA, and…
      Full distribution text Worldwide Distribution: USA, including the states of CA, CT, DE, FL, IA, KY, MA, MA, MI, MN, NJ, NY, OH, PA, TX, VA, and WI, and the country of Canada.
    • 23 Jun 2010 Z-2714-2011 Unclassified (pre-2012) 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. Distribution: Worldwide Distribution--USA (nationwide) and the country of Canada.
    • 22 Jun 2010 Z-0362-2011 Unclassified (pre-2012) 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 Distribution: Worldwide distribution: U.S. and country of Canada.
    • 1 Jun 2010 Z-0364-2011 Unclassified (pre-2012) 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. Distribution: Worldwide Distribution -- US, including states of CT, FL, IL, KY, GA, LA, IN, MS, NJ, NY, PA, OH, and TN and country of…
      Full distribution text Worldwide Distribution -- US, including states of CT, FL, IL, KY, GA, LA, IN, MS, NJ, NY, PA, OH, and TN and country of Canada.
    • 16 Feb 2010 Z-0344-2011 Unclassified (pre-2012) 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. Distribution: Nationwide Distribution - US and Puerto Rico.

  • 2009

    • 28 Aug 2009 Z-0360-2011 Unclassified (pre-2012) 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. Distribution: Nationwide distribution: AR, CA, FL, IL, IN, KS,LA, MA, MI, MN, MO, NC, ND,NH, NJ, NY, OH, PA, RI, TN, TX, VA and WI.

Frequently asked questions

How many devices does SCC SOFT COMPUTER have in the registry?

The registry currently lists 859 devices for SCC SOFT COMPUTER. Devices recorded under merged duplicate company entries are counted once.

Which registries list SCC SOFT COMPUTER's devices?

Among its 50 most recently registered devices, SCC SOFT COMPUTER has devices listed in FDA GUDID (50 devices).

What risk classes do SCC SOFT COMPUTER's devices fall under?

Among its 50 most recently registered devices, the classes recorded for SCC SOFT COMPUTER's devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for SCC SOFT COMPUTER?

FDA recall records list 38 recalls initiated by SCC SOFT COMPUTER, the most recent initiated on 31 Mar 2021. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from SCC SOFT COMPUTER in the registry?

The most recently registered devices listed for SCC SOFT COMPUTER include SoftBiochemistry 4.4.0.0, SoftCytogenetics 4.4.0.0, SoftPathDx 4.4.0.0 and SoftFlowCytometry 4.4.0.0.

Generated automatically from registry data and not verified by a human reviewer.