Class II — Soft Computer Consultants, Inc.
| Recalling firm | SCC SOFT COMPUTER |
|---|---|
| Registered facility | SCC SOFT COMPUTER (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Software showing wrong results reported, PDF not match HIS. |
| Product | SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting. |
| Quantity | 1 |
| Distribution | US Distribution to: CA only |
| Initiated | 2021-03-31 |
| Classified | 2021-07-19 |
| Terminated | 2022-04-15 |
| Recall number | Z-2093-2021 |
| 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 — Soft Computer Consultants, Inc. (Z-2093-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88095/
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