SoftLab with SA HIS versions 4 — Class II medical device recall Z-1038-2015
Terminated recall by SCC Soft Computer, reported 2015-02-11, distributed nationwide. The interface fails to send abnormal flags for Reference Lab test results.
| Recall number | Z-1038-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SCC Soft Computer, Clearwater, FL, United States |
| Recall initiated | 2014-05-20 |
| Classified | 2015-02-02 |
| Reported by FDA | 2015-02-11 |
| Terminated | 2016-05-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 48 |
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.
Reason for recall
The interface fails to send abnormal flags for Reference Lab test results.
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-1038-2015. 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.