Class II — SCC Soft Computer
| Recalling firm | SCC SOFT COMPUTER |
|---|---|
| Registered facility | SCC SOFT COMPUTER (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The interface fails to send abnormal flags for Reference Lab test results. |
| Product | SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory. |
| Quantity | 48 |
| 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, TN, WA, MN, SD, LA, NC, and NV and the country of Canada. |
| Initiated | 2014-05-20 |
| Classified | 2015-02-02 |
| Terminated | 2016-05-16 |
| Recall number | Z-1038-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — SCC Soft Computer (Z-1038-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70021/
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