SoftCytogenetics — Class II medical device recall Z-2098-2021
Terminated recall by Soft Computer Consultants, Inc., reported 2021-07-28, distributed nationwide. Software is given wrong results going out to HIS on test that had reruns.
| Recall number | Z-2098-2021 |
|---|---|
| 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 | 2023-02-14 |
| Distributed | Nationwide (US) |
| Quantity | 5 |
| Reason classes | software |
Product
SoftCytogenetics
Reason for recall
Software is given wrong results going out to HIS on test that had reruns.
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-2098-2021. 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.