RegWardenFDA facility compliance records
Company

SCC SOFT COMPUTER

8 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2011: 1 recalls; 2014: 3 recalls; 2016: 1 recalls; 2017: 1 recalls; 2021: 2 recalls1’11’12’133’14’151’161’17’18’19’202’21’22’23’24’25’26
  • Recalls (8)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2021-03-31
    Software is given wrong results going out to HIS on test that had reruns.
  • Class IITerminated2021-03-31
    Software showing wrong results reported, PDF not match HIS.
  • Class IITerminated2017-05-31
    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.
  • Class IITerminated2016-10-06
    Software error. Potential for incorrect results
  • Class IITerminated2014-11-26
    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.
  • Class IITerminated2014-05-20
    The interface fails to send abnormal flags for Reference Lab test results.
  • Class IITerminated2014-01-29
    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.
  • Class IITerminated2011-10-17
    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 Hematolog…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “SCC SOFT COMPUTER — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9011704-scc-soft-computer/

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