SoftGenomics version 4 — Class II medical device recall Z-2093-2021
Terminated recall by Soft Computer Consultants, Inc., reported 2021-07-28, distributed in CA. Software showing wrong results reported, PDF not match HIS.
| Recall number | Z-2093-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Soft Computer Consultants, Inc., Clearwater, FL, United States |
| Recall initiated | 2021-03-31 |
| Classified | 2021-07-19 |
| Reported by FDA | 2021-07-28 |
| Terminated | 2022-04-15 |
| Distributed | CA |
| Quantity | 1 |
| Reason classes | software |
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.
Reason for recall
Software showing wrong results reported, PDF not match HIS.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2093-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.