Class II — Soft Computer Consultants, Inc.
| Recalling firm | SCC SOFT COMPUTER |
|---|---|
| Registered facility | SCC SOFT COMPUTER (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, |
| Quantity | 18 units |
| Distribution | US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX. |
| Initiated | 2017-05-31 |
| Classified | 2017-08-02 |
| Terminated | 2020-08-04 |
| Recall number | Z-2865-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Soft Computer Consultants, Inc. (Z-2865-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77669/
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