RegWardenFDA facility compliance records
Facility

SCC SOFT COMPUTER

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

Activity by year

FDA actions on record by year2011: 1 recalls; 2014: 3 recalls; 2016: 1 recalls, 1 inspections; 2017: 1 recalls; 2021: 2 recalls1’11’12’133’14’152’161’17’18’19’202’21’22’23’24’25’26
  • Recalls (8)
  • Inspections (1)

Devices registered here (1)

  • Calculator/Data Processing Module, For Clinical Use
    Product code JQP (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.2100

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…

FDA inspections (1)

  • VAI2016-08-12
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SCC SOFT COMPUTER (FEI 1000307651) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000307651-scc-soft-computer/

Not open yet

Alerts for SCC SOFT COMPUTER

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.