SoftLab Software Laboratory information system to be used in a… — Class II medical device recall Z-2865-2017
Terminated recall by Soft Computer Consultants, Inc., reported 2017-08-09, distributed in CA, IL, LA, MA, MD, MI, MN, NJ…. Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a refe
| Recall number | Z-2865-2017 |
|---|---|
| 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 | 2017-05-31 |
| Classified | 2017-08-02 |
| Reported by FDA | 2017-08-09 |
| Terminated | 2020-08-04 |
| Distributed | CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, TX |
| Quantity | 18 units |
Product
SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
Reason for recall
Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the EMR.
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-2865-2017. 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.