SoftPath Laboratory Information System — Class II medical device recall Z-1065-2015
Terminated recall by SCC Soft Computer, reported 2015-02-18, distributed nationwide. Modifications to diagnostic text may be: 1) Saved to the database but not appear on the report sent to the phy
| Recall number | Z-1065-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SCC Soft Computer, Clearwater, FL, United States |
| Recall initiated | 2014-11-26 |
| Classified | 2015-02-09 |
| Reported by FDA | 2015-02-18 |
| Terminated | 2016-05-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 108 units |
Product
SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0
Reason for recall
Modifications to diagnostic text may be: 1) Saved to the database but not appear on the report sent to the physician; or 2) Documented on the report, but not saved to the database.
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-1065-2015. 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.